401 results on '"Reddy, UM"'
Search Results
2. Maternal serum fructosamine levels and stillbirth: a case–control study of the Stillbirth Collaborative Research Network
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Arslan, E, primary, Allshouse, AA, additional, Page, JM, additional, Varner, MW, additional, Thorsten, V, additional, Parker, C, additional, Dudley, DJ, additional, Saade, GR, additional, Goldenberg, RL, additional, Stoll, BJ, additional, Hogue, CJ, additional, Bukowski, R, additional, Conway, D, additional, Pinar, H, additional, Reddy, UM, additional, and Silver, RM, additional
- Published
- 2021
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3. Chronic hypertension, perinatal mortality and the impact of preterm delivery: a population‐based study
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Grover, S, primary, Brandt, JS, additional, Reddy, UM, additional, and Ananth, CV, additional
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- 2021
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4. Chronic hypertension, perinatal mortality and the impact of preterm delivery: a population‐based study.
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Grover, S, Brandt, JS, Reddy, UM, and Ananth, CV
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PERINATAL death ,PREMATURE labor ,HYPERTENSION risk factors ,HYPERTENSION ,BLOOD pressure - Abstract
Objectives: To estimate the association between chronic hypertension and perinatal mortality and to evaluate the extent to which risks are impacted by preterm delivery. Design: Cross‐sectional analysis. Setting: United States, 2015–18. Population: Singleton births (20–44 weeks of gestation). Exposure: Chronic hypertension, defined as elevated blood pressure diagnosed before pregnancy or recognised before 20 weeks of gestation. Main outcomes and measures: We derived the risk of perinatal mortality in relation to chronic hypertension from Poisson models, adjusted for confounders. The impacts of misclassification and unmeasured confounding were assessed. Causal mediation analysis was performed to quantify the impact of preterm delivery on the association. Results: Of the 15 090 678 singleton births, perinatal mortality rates were 22.5 and 8.2 per 1000 births in chronic hypertensive and normotensive pregnancies, respectively (adjusted risk ratio 2.05, 95% CI 2.00–2.10). Corrections for exposure misclassification and unmeasured confounding biases substantially increased the risk estimate. Although causal mediation analysis revealed that most of the association of chronic hypertension on perinatal mortality was mediated through preterm delivery, the perinatal mortality rates were highest at early term, term and late term gestations, suggesting that a planned early term delivery at 37–386/7 weeks may optimally balance risk in these pregnancies. Additionally, 87% (95% CI 84–90%) of perinatal deaths could be eliminated if preterm deliveries, as a result of chronic hypertension, were preventable. Conclusions: Chronic hypertension is associated with increased risk for perinatal mortality. Planned early term delivery and targeting modifiable risk factors for chronic hypertension may reduce perinatal mortality rates. Maternal chronic hypertension is associated with increased risk for perinatal mortality, largely driven by preterm birth. Maternal chronic hypertension is associated with increased risk for perinatal mortality, largely driven by preterm birth. [ABSTRACT FROM AUTHOR]
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- 2022
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5. Maternal serum fructosamine levels and stillbirth: a case–control study of the Stillbirth Collaborative Research Network.
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Arslan, E, Allshouse, AA, Page, JM, Varner, MW, Thorsten, V, Parker, C, Dudley, DJ, Saade, GR, Goldenberg, RL, Stoll, BJ, Hogue, CJ, Bukowski, R, Conway, D, Pinar, H, Reddy, UM, and Silver, RM
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STILLBIRTH ,GESTATIONAL diabetes ,GLYCEMIC control ,CASE-control method ,WATERSHEDS ,SECONDARY analysis - Abstract
Objective: To evaluate the association between maternal fructosamine levels at the time of delivery and stillbirth. Design: Secondary analysis of a case–control study. Setting: Multicentre study of five geographic catchment areas in the USA. Population: All singleton stillbirths with known diabetes status and fructosamine measurement, and representative live birth controls. Main outcome measures: Fructosamine levels in stillbirths and live births among groups were adjusted for potential confounding factors, including diabetes. Optimal thresholds of fructosamine to discriminate stillbirth and live birth. Results: A total of 529 women with a stillbirth and 1499 women with a live birth were included in the analysis. Mean fructosamine levels were significantly higher in women with a stillbirth than in women with a live birth after adjustment (177 ± 3.05 versus 165 ± 2.89 μmol/L, P < 0.001). The difference in fructosamine levels between stillbirths and live births was greater among women with diabetes (194 ± 8.54 versus 162 ± 3.21 μmol/L), compared with women without diabetes (171 ± 2.50 versus 162 ± 2.56 μmol/L). The area under the curve (AUC) for fructosamine level and stillbirth was 0.634 (0.605–0.663) overall, 0.713 (0.624–0.802) with diabetes and 0.625 (0.595–0.656) with no diabetes. Conclusions: Maternal fructosamine levels at the time of delivery were higher in women with stillbirth compared with women with live birth. Differences were substantial in women with diabetes, suggesting a potential benefit of glycaemic control in women with diabetes during pregnancy. The small differences noted in women without diabetes are not likely to justify routine screening in all cases of stillbirth. Maternal serum fructosamine levels are higher in women with stillbirth than in women with live birth, especially in women with diabetes. Maternal serum fructosamine levels are higher in women with stillbirth than in women live birth, especially in women with diabetes. [ABSTRACT FROM AUTHOR]
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- 2022
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6. Severe maternal morbidity during delivery hospitalisation in a large international administrative database, 2008–2013: a retrospective cohort
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Lipkind, HS, primary, Zuckerwise, LC, additional, Turner, EB, additional, Collins, JJ, additional, Campbell, KH, additional, Reddy, UM, additional, Illuzi, JL, additional, and Merriam, AA, additional
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- 2019
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7. Setting research priorities to improve global newborn health and prevent stillbirths by 2025
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Yoshida, S, Martines, J, Lawn, JE, Wall, S, Souza, JP, Rudan, I, Cousens, S, Aaby, P, Adam, I, Adhikari, RK, Ambalavanan, N, Arifeen, SE, Aryal, DR, Asiruddin, S, Baqui, A, Barros, AJ, Benn, CS, Bhandari, V, Bhatnagar, S, Bhattacharya, S, Bhutta, ZA, Black, RE, Blencowe, H, Bose, C, Brown, J, Bührer, C, Carlo, W, Cecatti, JG, Cheung, PY, Clark, R, Colbourn, T, Conde-Agudelo, A, Corbett, E, Czeizel, AE, Das, A, Day, LT, Deal, C, Deorari, A, Dilmen, U, English, M, Engmann, C, Esamai, F, Fall, C, Ferriero, DM, Gisore, P, Hazir, T, Higgins, RD, Homer, CS, Hoque, DE, Irgens, L, Islam, MT, de Graft-Johnson, J, Joshua, MA, Keenan, W, Khatoon, S, Kieler, H, Kramer, MS, Lackritz, EM, Lavender, T, Lawintono, L, Luhanga, R, Marsh, D, McMillan, D, McNamara, PJ, Mol, BW, Molyneux, E, Mukasa, GK, Mutabazi, M, Nacul, LC, Nakakeeto, M, Narayanan, I, Olusanya, B, Osrin, D, Paul, V, Poets, C, Reddy, UM, Santosham, M, Sayed, R, Schlabritz-Loutsevitch, NE, Singhal, N, Smith, MA, Smith, PG, Soofi, S, Spong, CY, Sultana, S, Tshefu, A, van Bel, F, Gray, LV, Waiswa, P, Wang, W, Williams, SL, Wright, L, Zaidi, A, Zhang, Y, Zhong, N, Zuniga, I, and Bahl, R
- Abstract
In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025.We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts.Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour.These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed.
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- 2016
8. Fabrication and evaluation of cefpodoxime proxetil niosomes
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Fouziya, Bandagisa, Hindustan, Abdul Ahad, Dontha, Swamy Charan, Jagarlamudi, Sri Vidya, Reddy, Ummadi Chandana, and Reddy, Puli Nandini
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- 2022
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9. Neonatal complications associated with use of fetal scalp electrode: a retrospective study
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Kawakita, T, primary, Reddy, UM, additional, Landy, HJ, additional, Iqbal, SN, additional, Huang, C-C, additional, and Grantz, KL, additional
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- 2015
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10. Unravelling caesarean delivery as a risk factor for antepartum stillbirth
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Reddy, UM, primary
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- 2015
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11. Neonatal complications associated with use of fetal scalp electrode: a retrospective study.
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Kawakita, T, Reddy, UM, Landy, HJ, Iqbal, SN, Huang, C‐C, Grantz, KL, Reddy, U M, Landy, H J, Iqbal, S N, Huang, C-C, and Grantz, K L
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DELIVERY (Obstetrics) , *FETAL diseases , *GESTATIONAL age , *SCALP , *DISEASE risk factors , *WOUNDS & injuries , *BIRTH injuries , *ELECTRODES , *FETAL heart rate monitoring , *RESEARCH funding , *DISEASE incidence , *RETROSPECTIVE studies , *ODDS ratio ,PREGNANCY complication risk factors ,FETAL heart rate monitoring equipment - Abstract
Objectives: To estimate the incidence and risk of complications associated with a fetal scalp electrode and to determine whether its application in the setting of operative vaginal delivery was associated with increased neonatal morbidity.Design: Retrospective cohort study.Setting: Twelve clinical centers with 19 hospitals across nine American Congress of Obstetricians and Gynecologists US districts.Population: Women in the USA.Methods: We evaluated 171 698 women with singleton deliveries ≥ 23 weeks of gestation in a secondary analysis of the Consortium on Safe Labor study between 2002 and 2008, after excluding conditions that precluded fetal scalp electrode application such as prelabour caesarean delivery. Secondary analysis limited to operative vaginal deliveries ≥ 34 weeks of gestation was also performed.Main Outcome Measures: Incidences and adjusted odds ratios with 95% confidence intervals of neonatal complications were calculated, controlling for maternal characteristics, delivery mode and pregnancy complications.Results: Fetal scalp electrode was used in 37 492 (22%) of deliveries. In non-operative vaginal delivery, fetal scalp electrode was associated with increased risk of injury to scalp due to birth trauma (1.2% versus 0.9%; adjusted odds ratios 1.62; 95% confidence intervals 1.41-1.86) and cephalohaematoma (1.0% versus 0.9%; adjusted odds ratios 1.57; 95% confidence intervals 1.36-1.83). Neonatal complications were not significantly different comparing fetal scalp electrode with vacuum-assisted vaginal delivery and vacuum-assisted vaginal delivery alone or comparing fetal scalp electrode with forceps-assisted vaginal delivery and forceps-assisted vaginal delivery alone.Conclusions: We found increased neonatal morbidity with fetal scalp electrode though the absolute risk was very low. It is possible that these findings reflect an underlying indication for its use. Our findings support the use of fetal scalp electrodes when clinically indicated.Tweetable Abstract: Neonatal risks associated with fetal scalp electrode use were low (injury to scalp 1.2% and cephalohaematoma 1.0%). [ABSTRACT FROM AUTHOR]- Published
- 2016
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12. Recurrence risk of stillbirth in the second pregnancy
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Herring, AH, primary and Reddy, UM, additional
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- 2010
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13. The association of beta-2 adrenoceptor genotype with short-cervix mediated preterm birth: a case-control study.
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Miller, R, Smiley, R, Thom, EA, Grobman, WA, Iams, JD, Mercer, BM, Saade, G, Tita, AT, Reddy, UM, Rouse, DJ, Sorokin, Y, Blackwell, SC, Esplin, MS, Tolosa, JE, and Caritis, SN
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GENOTYPES ,PREMATURE labor ,PREMATURE infants ,BETA adrenoceptors ,DURATION of pregnancy ,LABOR complications (Obstetrics) - Abstract
Objective To determine whether β
2 -adrenoceptor ( β2 AR) genotype is associated with shortening of the cervix or with preterm birth ( PTB) risk among women with a short cervix in the second trimester. Design A case-control ancillary study to a multicentre randomised controlled trial. Setting Fourteen participating centres of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Population Four hundred thirty-nine women, including 315 with short cervix and 124 with normal cervical length. Methods Nulliparous women with cervical length <30 mm upon a 16-22-week transvaginal sonogram and controls frequency-matched for race/ethnicity with cervical lengths ≥40 mm were studied. β2 AR genotype was determined at positions encoding for amino acid residues 16 and 27. Main outcome measures Genotype distributions were compared between case and control groups. Within the short cervix group, pregnancy outcomes were compared by genotype, with a primary outcome of PTB <37 weeks. Results Genotype data were available at position 16 for 433 women and at position 27 for 437. Using a recessive model testing for association between short cervix and genotype, and adjusted for ethnicity, there was no statistical difference between cases and controls for Arg16 homozygosity ( OR 0.7, 95% CI 0.4-1.3) or Gln27 homozygosity ( OR 0.9, 95% CI 0.3-2.7). Among cases, Arg16 homozygosity was not associated with protection from PTB or spontaneous PTB. Gln27 homozygosity was not associated with PTB risk, although sample size was limited. Conclusions β2 AR genotype does not seem to be associated with short cervical length or with PTB following the second-trimester identification of a short cervix. Influences on PTB associated with β2 AR genotype do not appear to involve a short cervix pathway. [ABSTRACT FROM AUTHOR]- Published
- 2015
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14. Socioeconomic and Regional Disparities in Under-Five Mortality in India
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Yadav, Jeetendra, Yadav, Ashish Kr, Reddy, Umenthala Srikanth, and Singh, KH Jitenkumar
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- 2018
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15. Assessment of quality of life of cancer patients in a tertiary care hospital of South India.
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Kannan G, Rani V, Ananthanarayanan RM, Palani T, Nigam N, Janardhan V, and Reddy UM
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- 2011
16. Term pregnancy: a period of heterogeneous risk for infant mortality.
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Reddy UM, Bettegowda VR, Dias T, Yamada-Kushnir T, Ko CW, Willinger M, Reddy, Uma M, Bettegowda, Vani R, Dias, Todd, Yamada-Kushnir, Tomoko, Ko, Chia-Wen, and Willinger, Marian
- Abstract
Objective: To estimate the trend of maternal racial and ethnic differences in mortality for early-term (37 0/7 to 38 6/7 weeks of gestation) compared with full-term births (39 0/7 to 41 6/7 weeks of gestation).Methods: We analyzed 46,329,018 singleton live births using the National Center for Health Statistics U.S. period-linked birth and infant death data from 1995 to 2006. Infant mortality rates, neonatal mortality rates, and postneonatal mortality rates were calculated according to gestational age, race and ethnicity, and cause of death.Results: Overall, infant mortality rates have decreased for early-term and full-term births between 1995 and 2006. At 37 weeks of gestation, Hispanics had the greatest decline in infant mortality rates (35.4%; 4.8 per 1,000 to 3.1 per 1,000) followed by 22.4% for whites (4.9 per 1,000 to 3.8 per 1,000); blacks had the smallest decline (6.8%; 5.9 per 1,000 to 5.5 per 1,000) as a result of a stagnant neonatal mortality rate. At 37 weeks compared with 40 weeks of gestation, neonatal mortality rates increase. For Hispanics, the relative risk is 2.6 (95% confidence interval [CI] 2.0-3.3); for whites, the relative risk is 2.6 (95% CI 2.2-3.1); and for blacks, the relative risk is 2.9 (95% CI 2.2-3.8). Neonatal mortality rates are still increased at 38 weeks of gestation. At both early- and full-term gestations, neonatal mortality rates for blacks are 40% higher than for whites and postneonatal mortality rates 80% higher, whereas Hispanics have a reduced postneonatal mortality rate when compared with whites.Conclusion: Early-term births are associated with higher neonatal, postneonatal, and infant mortality rates compared with full-term births with concerning racial and ethnic disparity in rates and trends. [ABSTRACT FROM AUTHOR]- Published
- 2011
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17. Prediction and prevention of recurrent stillbirth.
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Reddy UM and Reddy, Uma M
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Stillbirth is one of the most common adverse pregnancy outcomes in the United States, occurring in one out of every 200 pregnancies. There is a paucity of information on the outcome of pregnancies after stillbirth. Prior stillbirth is associated with a twofold to 10-fold increased risk of stillbirth in the future pregnancy. The risk depends on the etiology of the prior stillbirth, presence of fetal growth restriction, gestational age of the prior stillbirth, and race. Categorization of the cause of the initial stillbirth will allow better estimates of individual recurrence risk and guide management. A history of stillbirth also increases the risk of other adverse pregnancy outcomes in the subsequent pregnancy such as placental abruption, cesarean delivery, preterm delivery, and low birth weight infants. Prospective studies have revealed an increased risk of stillbirth with low pregnancy-associated plasma protein A, elevated maternal serum alpha fetoprotein, abnormal uterine artery Doppler studies, and antiphospholipid antibodies. However, the positive predictive value of these factors individually is poor. Because fetal growth restriction is associated with almost half of all stillbirths, the correct diagnosis of fetal growth restriction is essential. The use of individualized or customized growth standards will improve prediction of adverse pregnancy outcome by distinguishing growth-restricted fetuses from constitutionally small, healthy fetuses. Antepartum fetal surveillance and fetal movement counting are also mainstays of poststillbirth pregnancy management. [ABSTRACT FROM AUTHOR]
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- 2007
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18. Comparison of first and second trimester aneuploidy risk assessment.
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Reddy UM and Wapner RJ
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Counseling regarding the options for aneuploidy risk assessment is complicated and requires thorough counseling with the patient. Second trimester serum risk assessment has been the gold standard because of widespread availability, low cost, and vast experience with counseling and performance. First trimester risk assessment is becoming more widely available and provides increased sensitivity for Down syndrome detection with a detection rate of approximately 87% (95% confidence interval: 84.0% to 89.4%), at a fixed false-positive rate of 5%. With the advent of first trimester techniques, controversy has arisen as there are advocates for the different recently available approaches. In this chapter, we outline the various options in a manner that will provide practical information for physicians offering such testing. Clearly, implementation of first trimester risk assessment requires special training and meticulous quality control standards for nuchal translucency and laboratory measurements, access to chorionic villus sampling, and also appropriate counseling regarding risk assessment options. [ABSTRACT FROM AUTHOR]
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- 2007
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19. Recurrent pregnancy loss: nongenetic causes.
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Reddy UM
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Despite a comprehensive evaluation, the cause of recurrent pregnancy loss can't be identified for more than half of affected couples. Cautious reassurance and encouragement are important--as is careful monitoring. [ABSTRACT FROM AUTHOR]
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- 2007
20. Infertility, assisted reproductive technology, and adverse pregnancy outcomes: executive summary of a National Institute of Child Health and Human Development workshop.
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Reddy UM, Wapner RJ, Rebar RW, and Tasca RJ
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- 2007
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21. Incorporating first-trimester Down syndrome studies into prenatal screening: executive summary of the National Institute of Child Health and Human Development workshop.
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Reddy UM and Mennuti MT
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The National Institute of Child Health and Human Development (NICHD), the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists (ACOG), cosponsored a workshop on December 16-17, 2004, to discuss the evidence for first-trimester Down syndrome screening and to explore the effects of combining first- and second-trimester screening, given the results of recent U.S. trials. The experts evaluated the evidence for offering first-trimester screening to provide individual risk assessment for Down syndrome. First-trimester screening has been demonstrated to provide efficient Down syndrome risk assessment, with a detection rate of 84% (95% confidence interval 80-87%), which is clinically comparable to the second-trimester quadruple screen at a fixed false-positive rate of 5%. The participants at the workshop concluded that at this time there is sufficient evidence to support implementing first-trimester Down syndrome risk assessment in obstetric practice in the United States, provided that certain requirements can be met. These requirements include training and quality control standards for first-trimester nuchal translucency measurement and laboratory assays, access to chorionic villus sampling, and appropriate counseling regarding screening options. [ABSTRACT FROM AUTHOR]
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- 2006
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22. Relationship of maternal body mass index and height to twinning.
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Reddy UM, Branum AM, and Klebanoff MA
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- 2005
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23. The evolving prenatal screening scene.
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Reddy UM
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- 2007
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24. Redo mitral valve surgery on beating heart
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Sheikh, Shabir Ahmad, Erikat, Zaid, Tarief, Habib, Bukamal, Nazar, and Reddy, Umesh
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- 2010
25. Stillbirth.
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REDDY UM
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- 2010
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26. Antepartum yoga and pregnancy outcomes in nulliparous individuals: a retrospective cohort study.
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Kawakita T, Atwani R, Huang JC, Greenland P, Merz CNB, Grobman WA, Christman M, Silver RM, Mcneil RB, Reddy UM, Chung JH, Parry S, and Saade GR
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- 2024
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27. Postpartum readmission risk: a comparison between stillbirths and live births.
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Sweeney LC, Reddy UM, Campbell K, and Xu X
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- Humans, Female, Adult, Pregnancy, Retrospective Studies, Risk Factors, Postpartum Period, United States epidemiology, Young Adult, Venous Thromboembolism epidemiology, Patient Readmission statistics & numerical data, Stillbirth epidemiology, Live Birth epidemiology
- Abstract
Background: Stillbirth occurs more commonly among pregnant people with comorbid conditions and obstetrical complications. Stillbirth also independently increases maternal morbidity and imparts a psychosocial hazard when compared with live birth. These distinct needs and burden may increase the risk for postpartum readmission after stillbirth., Objective: This study aimed to examine the risk for maternal postpartum readmission after stillbirth in comparison with live birth and to identify indications for readmission and the associated risk factors., Study Design: This was a retrospective cohort of patients with singleton stillbirths or live births, delivered at ≥20 weeks' gestation, who were identified from the 2019 Nationwide Readmissions Database. The primary outcome was all-cause readmission within 6 weeks of discharge from the childbirth hospitalization. The association between stillbirth (vs live birth) and risk for readmission was assessed using multivariable regression models with adjustment for maternal age, sociodemographic characteristics, maternal and obstetrical conditions, and delivery characteristics. Within the stillbirth group, risk factors for readmission were further examined using multivariable regression. The secondary outcomes included principal indication for readmission (categorized based on principal diagnosis code of the readmission hospitalization) and timing of readmission (number of weeks after childbirth hospitalization). Differences in these secondary outcomes were compared between the stillbirth and live birth groups using chi-square tests. All analyses accounted for the complex sample design to generate nationally representative estimates., Results: Postpartum readmission occurred in 2.7% of 16,636 patients with stillbirths, whereas it occurred in 1.6% of 2,870,677 patients with live births (unadjusted risk ratio, 1.65; 95% confidence interval, 1.47-1.86). The higher risk for readmission after stillbirth (vs live birth) persisted after adjusting for maternal, obstetrical, and delivery characteristics (adjusted risk ratio, 1.27; 95% confidence interval, 1.11-1.46). The distribution of principal indication for readmission differed after stillbirth and after live birth and included hypertension (30.2% vs 39.5%; unadjusted risk ratio, 0.76; 95% confidence interval, 0.63-0.93), mental health or substance use disorders (6.8% vs 3.6%; unadjusted risk ratio, 1.90; 95% confidence interval, 1.15-3.16), and venous thromboembolism (5.8% vs 2.0%; unadjusted risk ratio, 2.87; 95% confidence interval, 1.60-5.17). Among patients with stillbirths, 56.0% of readmissions occurred within 1 week, 71.8% within 2 weeks, and 88.1% within 4 weeks; the timing of readmission did not differ significantly between the stillbirth and live birth cohorts. Pregestational diabetes (adjusted risk ratio, 1.87; 95% confidence interval, 1.20-2.93), gestational diabetes (adjusted risk ratio, 1.67; 95% confidence interval, 1.03-2.71), hypertensive disorders of pregnancy (adjusted risk ratio, 1.80; 95% confidence interval, 1.31-2.47), obesity (adjusted risk ratio, 1.46; 95% confidence interval, 1.01-2.12), and primary cesarean delivery (adjusted risk ratio, 1.74; 95% confidence interval, 1.17-2.58) were associated with a higher risk for readmission after stillbirth, whereas higher household income was associated with a lower risk for readmission (eg, adjusted risk ratio for income ≥$82,000 vs $1-$47,999, 0.48; 95% confidence interval, 0.30-0.77)., Conclusion: When compared with live births, the risk for postpartum readmission was higher after stillbirths, even after adjustment for differences in the patient demographic and clinical characteristics. Readmission for mental health or substance use disorders and venous thromboembolism is more common after stillbirths than after live births., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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28. Pregnancy Outcomes in Patients With Hepatitis C Virus Infection.
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Hughes BL, Sandoval GJ, Saade GR, Clifton RG, Reddy UM, Bartholomew A, Salazar A, Chien EK, Tita ATN, Thorp JM Jr, Metz TD, Wapner RJ, Sabharwal V, Simhan HN, Swamy GK, Heyborne KD, Sibai BM, Grobman WA, El-Sayed YY, Casey BM, Parry S, Macones GA, and Prasad M
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- Humans, Female, Pregnancy, Adult, Infant, Newborn, Prospective Studies, Case-Control Studies, Infant, Small for Gestational Age, Premature Birth epidemiology, Young Adult, Intensive Care Units, Neonatal statistics & numerical data, Pregnancy Complications, Infectious epidemiology, Pregnancy Outcome epidemiology, Hepatitis C epidemiology, Hepatitis C complications
- Abstract
Objective: To evaluate the risks of adverse maternal and neonatal outcomes associated with pregnancies complicated by hepatitis C virus (HCV) infection., Methods: This is a secondary analysis of a multicenter prospective cohort study of HCV infection in pregnancy. Participants were screened for HCV infection with serum antibody tests, and each participant with a positive HCV result (case group) was matched with up to two individuals with negative HCV results (control group) prospectively by gestational age (±2 weeks) at enrollment. Maternal outcomes included gestational diabetes, abruption, preeclampsia or gestational hypertension, cholestasis, and preterm delivery. Neonatal outcomes included hyperbilirubinemia, admission to neonatal intensive care (NICU); small-for-gestational-age (SGA) birth weight; and neonatal infection , defined as sepsis or pneumonia. Models were adjusted for maternal age, body mass index, injection drug use, and maternal medical comorbidities., Results: The 249 individuals in the case group were prospectively matched to 486 individuals in the control group who met eligibility criteria. There were significant differences in demographic characteristics between the groups, including race, socioeconomic markers, education, insurance status, and drug and tobacco use. The frequencies of maternal outcomes of gestational diabetes, preeclampsia, and abruption were similar between the case and control groups. Preterm birth was similar between groups, but neonates born to individuals in the case group were more likely to be admitted to the NICU (45.1% vs 19.0%, adjusted odds ratio [aOR] 2.6, 95% CI, 1.8-3.8) and to have SGA birth weights below the 5th percentile (10.6% vs 3.1%, aOR 2.9, 95% CI, 1.4-6.0). There were no increased odds of hyperbilirubinemia or neonatal infection., Conclusion: Despite no increased odds of preterm birth or other adverse maternal outcomes in adjusted analyses, maternal HCV infection was associated with twofold increased odds of NICU admission and nearly threefold increased odds of SGA birth weight below the 5th percentile., Competing Interests: Financial Disclosure Brenna Hughes reports an ongoing financial relationship with UpToDate. Rebecca Clifton reports funding from the University of Arkansas for Medical Sciences for DSMB meetings and from the NIH to her institution. Anna Bartholomew reports money paid to her institution by NICHD and George Washington University. Alan Tita reports money paid to his institution from Pfizer. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Money was paid to her institution from Pfizer (site PI for phase III respiratory syncytial virus [RSV] vaccine trial and site PI for a COVID-19 vaccination trial in pregnancy). Geeta Swamy reports receiving past funding from GlaxoSmithKline and ongoing funding from Pfizer, Medscape, UpToDate, Moderna, and Sanofi. The other authors did not disclose any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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29. Infection and Sepsis Trends during United States' Delivery Hospitalizations from 2000 to 2020.
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Liu LY, Friedman AM, Goffman D, Nathan L, Sheen JJ, Reddy UM, D'Alton ME, and Wen T
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- Humans, Female, Adult, United States epidemiology, Pregnancy, Cross-Sectional Studies, Middle Aged, Young Adult, Adolescent, Risk Factors, Chorioamnionitis epidemiology, Pregnancy Complications, Infectious epidemiology, Delivery, Obstetric, Logistic Models, Pyelonephritis epidemiology, Pneumonia epidemiology, Sepsis epidemiology, Hospitalization statistics & numerical data, Endometritis epidemiology
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Objective: This study aimed to evaluate trends, risk factors, and outcomes associated with infections and sepsis during delivery hospitalizations in the United States., Study Design: The 2000-2020 National Inpatient Sample was used for this repeated cross-sectional analysis. Delivery hospitalizations of patients aged 15 to 54 with and without infection and sepsis were identified. Common infection diagnoses during delivery hospitalizations analyzed included (i) pyelonephritis, (ii) pneumonia/influenza, (iii) endometritis, (iv) cholecystitis, (v) chorioamnionitis, and (vi) wound infection. Temporal trends in sepsis and infection during delivery hospitalizations were analyzed. The associations between sepsis and infection and common chronic health conditions including asthma, chronic hypertension, pregestational diabetes, and obesity were analyzed. The associations between clinical, demographic, and hospital characteristics, and infection and sepsis were determined with unadjusted and adjusted logistic regression models with unadjusted odds ratio (OR) and adjusted odds ratios with 95% confidence intervals as measures of association., Results: An estimated 80,158,622 delivery hospitalizations were identified and included in the analysis, of which 2,766,947 (3.5%) had an infection diagnosis and 32,614 had a sepsis diagnosis (4.1 per 10,000). The most common infection diagnosis was chorioamnionitis (2.7% of deliveries) followed by endometritis (0.4%), and wound infections (0.3%). Infection and sepsis were more common in the setting of chronic health conditions. Evaluating trends in individual infection diagnoses, endometritis and wound infection decreased over the study period both for patients with and without chronic conditions, while risk for pyelonephritis and pneumonia/influenza increased. Sepsis increased over the study period for deliveries with and without chronic condition diagnoses. Risks for adverse outcomes including mortality, severe maternal morbidity, the critical care composite, and acute renal failure were all significantly increased in the presence of sepsis and infection., Conclusion: Endometritis and wound infections decreased over the study period while risk for sepsis increased. Infection and sepsis were associated with chronic health conditions and accounted for a significant proportion of adverse obstetric outcomes including severe maternal morbidity., Key Points: · Sepsis increased over the study period for deliveries with and without chronic condition diagnoses.. · Endometritis and wound infection decreased over the study period.. · Infection and sepsis accounted for a significant proportion of adverse obstetric outcomes.., Competing Interests: M.E.D'A. had a senior leadership role in ACOG II's Safe Motherhood Initiative which received unrestricted funding from Merck for Mothers. A.M.F. is supported by funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (1R01HD104943), however, this funding was not used to support this research. A.M.F. has also served on an advisory board for Biogen and Sage. T.W. serves as a consultant on the medical advisory board for Delfina, Inc. D.G. serves on the scientific advisory board for the Jada device through Organon and the Cooper Surgical Obstetrical Safety Council. The other authors did not report any potential conflict of interest., (Thieme. All rights reserved.)
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- 2024
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30. Diet quality, community food access, and glycemic control among nulliparous individuals with diabetes.
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Venkatesh KK, Yee LM, Wu J, Joseph JJ, Garner J, McNeil R, Scifres C, Mercer B, Reddy UM, Silver RM, Saade G, Parry S, Simhan H, Post RJ, Walker DM, and Grobman WA
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- Humans, Female, Pregnancy, Adult, Food Insecurity, Food Supply, Young Adult, Nutritional Status, Cross-Sectional Studies, Glycated Hemoglobin metabolism, Maternal Nutritional Physiological Phenomena, Glycemic Control, Blood Glucose metabolism, Parity, Pregnancy in Diabetics blood, Pregnancy in Diabetics diagnosis, Diet, Healthy, Nutritive Value, Biomarkers blood
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Better diet quality regardless of community food access was associated with a higher likelihood of glycemic control in early pregnancy among nulliparous individuals with pregestational diabetes. These findings highlight the need for interventions that address nutrition insecurity for pregnant individuals living with diabetes., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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31. Oxytocin regimen used for induction of labor and pregnancy outcomes.
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Reddy UM, Sandoval GJ, Tita ATN, Silver RM, Mallett G, Hill K, El-Sayed YY, Rice MM, Wapner RJ, Rouse DJ, Saade GR, Thorp JM, Chauhan SP, Costantine MM, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN, Macones GA, and Grobman WA
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Background: Following the results of the ARRIVE trial, which demonstrated a reduction in cesarean delivery with no increase in adverse perinatal outcomes after elective induction of labor (IOL) in low-risk nulliparous patients at 39 weeks' gestation compared with expectant management, the use of induction has increased. Current evidence is insufficient to recommend mid-high-dose over low-dose regimens for routine IOL., Objective(s): We sought to evaluate the association of oxytocin regimen with cesarean delivery and an adverse perinatal composite outcome in low-risk nulliparous patients undergoing IOL at 39 weeks of gestation or greater., Study Design: This is a secondary analysis of the NICHD Maternal-Fetal Medicine Units Network ARRIVE randomized trial. Patients induced with a mid-to high-dose oxytocin regimen (MHD; starting or incremental increase >2 mU/min) were compared with those receiving a low-dose oxytocin regimen (LD; starting and incremental increase ≤2 mU/min). The co-primary outcomes for this secondary analysis were 1) cesarean delivery and 2) composite of perinatal death or severe neonatal complications. Multivariable Poisson regression was used to estimate adjusted relative risks (aRR) and 97.5% confidence intervals (CI) for the co-primary endpoints, 95% CI for binomial outcomes and multinomial logistic regression was used to estimate adjusted odds ratios (aOR) and 95% CIs for multinomial outcomes., Results: Of 6,106 participants enrolled in the primary trial, 2,933 underwent induction with oxytocin: 861 in the MHD group and 2,072 in the LD group. The lower frequency of cesarean delivery in the MHD group compared with the LD group (20.3% vs. 25.2%, RR 0.81, 95%CI (0.69-0.94)) was not significant after adjustment (aRR 0.90, 97.5%CI (0.76-1.07)). The composite of perinatal death or severe neonatal complications was more frequent in the MHD group compared with the LD group (6.7% vs. 4.3%, RR 1.55, 95%CI (1.13-2.14)) and remained significant after adjustment (aRR 1.61, 97.5%CI (1.11-2.35)). The majority of the cases in the composite were from the respiratory support (5.2% vs. 3.1%) component with an increase in transient tachypnea of the newborn (3.8% vs. 2.5%, aRR 1.63, 95% CI (1.04-2.54)). The duration of neonatal respiratory support for one day was significantly higher in the MHD group compared with the LD group (3.5% vs. 1.4%, aRR 2.59, 95%CI (1.52-4.39)); however, support beyond one day was not different between the two groups. The MHD group, when compared with the LD group had a higher operative vaginal delivery rate (10.0% vs. 7.0%, aRR 1.54, 95%CI (1.18-2.00)) and shorter duration of time from start of oxytocin to delivery [crude median (interquartile range) 12 (8-17) vs. 13 (9-19) hours, adjusted median difference -2 (-2 to -1), p<0.001], respectively., Conclusion(s): Mid-high-dose oxytocin regimen use for IOL in nulliparas at ≥ 39 weeks' gestation was not associated with improved maternal or neonatal outcomes compared with low-dose regimens. Although mid-high-dose oxytocin regimen use was associated with a shorter duration of labor, there was an increase in self-limited neonatal respiratory support and no difference in cesarean rates. More evidence is needed to define the magnitude of potential maternal and neonatal benefits and risks associated with oxytocin regimens., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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32. Patient and community centered approaches to sepsis among birthing people.
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Richardson BT, Cepin A, Grilo S, Moss RA, Moller MD, Brown S, Goffman D, Friedman A, Reddy UM, and Hall KS
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Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black and living in underserved communities, labor and postpartum are particularly vulnerable risk periods. To reduce sepsis-related morbidity and mortality and promote maternal health equity, community co-led, and co-designed interventions are urgently needed. In this commentary, we introduce the design and goals of our EnCoRe MoMS study as an exemplar for employing community based participatory research principals iteratively throughout the research process and integrated across all study aims. We also highlight our early lessons learned and recommendations for best practices. Our novel model and ongoing work have implications for scaling academic-community research partnerships for other causes of severe maternal morbidity and maternal health equity nationally., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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33. The association between perinatal depressive symptoms and child neurodevelopment.
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Miller ES, Costantine MM, Mele L, Varner MW, Reddy UM, Wapner RJ, Thorp JM Jr, Saade GR, Tita ATN, Rouse DJ, Sibai B, Mercer BM, Caritis SN, and Casey BM
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Background: Perinatal depression has been suggested to adversely impact child neurodevelopment. However, the complexity of the early childhood environment challenges conclusive findings., Objective: To evaluate whether there is an association between perinatal depressive symptoms and child intelligence quotient (IQ) at 5 years of age., Study Design: Secondary analysis of an ancillary study to a multicenter randomized trial of thyroxine therapy for pregnant individuals with subclinical hypothyroidism. Dyads of infants and birthing parent, with completed Center for Epidemiological Studies-Depression (CES-D) screens during pregnancy and postpartum and child neurodevelopment testing completed at five years of age (n=209) were included. CES-D screening was performed at 11-20 weeks, 34-38 weeks, and one-year postpartum. Depressive symptoms were categorized as antenatal (i.e., a positive screen at any point during pregnancy) or postpartum. The primary outcome was child IQ score < 85 at 5 years of age using the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) Full Scale test. Secondary outcomes included other assessments of childhood neurodevelopment. Bivariable analyses and multivariable logistic regressions were utilized., Results: Of the 209 birthing people included, 72 (34%) screened positive for depression during pregnancy and 32 (15%) screened positive one year postpartum. Children born to individuals with a positive antenatal depression screen had a higher odds of IQ < 85 at 5 years of age compared with children born to individuals with a CES-D < 16 (35% vs. 18%, OR 2.4, 95% CI 1.2-4.7). Similar findings were seen for children born to individuals with a positive postpartum depression screen (47% vs. 21%, OR 3.3, 95% CI 1.5-7.3). These associations did not persist in multivariable analyses that controlled for social determinants of health and clinical characteristics (adjusted odd ratio [aOR] 1.4, 95% CI 0.7-3.1; aOR 2.1, 95% CI 0.9-5.1, for antenatal and postpartum depressive symptoms, respectively). Similar findings were observed for other adverse neurodevelopmental outcomes., Conclusions: Having a positive perinatal depression screen was not associated with child cognitive outcomes after controlling for covariates including social determinants of health., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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34. Blood pressure control in pregnant patients with chronic hypertension and diabetes: should <130/80 be the target?
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Harper LM, Kuo HC, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey BM, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe K, Foroutan J, Tuuli MG, Owens MY, Simhan HN, Frey HA, Rosen T, Palatnik A, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Galis ZS, Ambalavanan N, Oparil S, Szychowski JM, and Tita ATN
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Background: The Chronic Hypertension and Pregnancy Study demonstrated that a target blood pressure of <140/90 mm Hg during pregnancy is associated with improved perinatal outcomes. Outside of pregnancy, pharmacologic therapy for patients with diabetes and hypertension is adjusted to a target blood pressure of <130/80 mm Hg. During pregnancy, patients with both diabetes and chronic hypertension may also benefit from tighter control with a target blood pressure <130/80 mm Hg., Objective: We compared perinatal outcomes in patients with hypertension and diabetes who achieved blood pressure <130/80 vs 130 to 139/80 to 89 mm Hg., Study Design: This was a secondary analysis of a multcenter randomized controlled trial. Participants were included in this secondary analysis if they had diabetes diagnosed prior to pregnancy or at <20 weeks of gestation and at least 2 recorded blood pressure measurements prior to delivery. Average systolic and diastolic blood pressure were calculated using ambulatory antenatal blood pressures. The primary composite outcome was preeclampsia with severe features, indicated preterm birth <35 weeks, or placental abruption. Secondary outcomes were components of the primary outcome, cesarean delivery, fetal or neonatal death, neonatal intensive care unit admission, and small for gestational age. Comparisons were made between those with an average systolic blood pressure <130 mm Hg and average diastolic blood pressure <80 mm Hg and those with an average systolic blood pressure 130 to 139 mm Hg or diastolic blood pressure 80 to 89 mm Hg using Student's t test and chi-squared tests. Multivariable log-binomial regression models were used to evaluate risk ratios between blood pressure groups for dichotomous outcomes while accounting for baseline covariates., Results: Of 434 participants included, 150 (34.6%) had an average blood pressure less than 130/80 mm Hg. Participants with an average blood pressure less than 130/80 were more likely to be on antihypertensive medications at the start of pregnancy and more likely to have newly diagnosed diabetes mellitus prior to 20 weeks. Participants with an average blood pressure less than 130/80 mm Hg were less likely to have the primary adverse perinatal outcome (19.3% vs 46.5%, adjusted relative risk 0.43, 95% confidence interval 0.30-0.61, P<.01), with decreased risks specifically of preeclampsia with severe features (adjusted relative risk 0.35, 95% confidence interval 0.23-0.54) and indicated preterm birth prior to 35 weeks (adjusted relative risk 0.44, 95% confidence interval 0.24-0.79). The risk of neonatal intensive care unit admission was lower in the lower blood pressure group (adjusted relative risk 0.74, 95% confidence interval 0.59-0.94). No differences were noted in cesarean delivery (adjusted relative risk 1.04, 95% confidence interval 0.90-1.20), fetal or neonatal death (adjusted relative risk 0.59, 95% confidence interval 0.12-2.92). Small for gestational age less than the 10th percentile was lower in the lower blood pressure group (adjusted relative risk 0.37, 95% confidence interval 0.14-0.96)., Conclusion: In those with chronic hypertension and diabetes prior to 20 weeks, achieving an average goal blood pressure of <130/80 mm Hg may be associated with improved perinatal outcomes., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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35. Progression of Gestational Subclinical Hypothyroidism and Hypothyroxinemia to Overt Hypothyroidism After Pregnancy: Pooled Analysis of Data from Two Randomized Controlled Trials.
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Varner MW, Mele L, Casey BM, Peaceman AM, Reddy UM, Wapner RJ, Thorp JM, Saade GR, Tita ATN, Rouse DJ, Sibai BM, Costantine MM, Mercer BM, and Caritis SN
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- Humans, Female, Pregnancy, Adult, Iodide Peroxidase immunology, Incidence, Randomized Controlled Trials as Topic, Thyroid Function Tests, Hypothyroidism blood, Hypothyroidism drug therapy, Thyroxine blood, Disease Progression, Pregnancy Complications blood, Pregnancy Complications drug therapy, Thyrotropin blood
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Background: To examine the incidence of overt hypothyroidism 1 and 5 years after pregnancies where screening before 21 weeks identified subclinical hypothyroidism (SH) or hypothyroxinemia (HT). Methods: Secondary analysis of two multicenter treatment trials for either SH or HT diagnosed between 8 and 20 weeks gestation. Current analyses focus only on individuals randomized to the placebo groups in the two parallel studies. SH was diagnosed with thyrotropin (TSH) ≥4.0 mU/L and normal free T4 (fT4) (0.86-1.9 ng/dL). HT was diagnosed with normal TSH (0.08-3.99 mU/L) but fT4 <0.86 ng/dL. Serum from initial testing was stored for later thyroid peroxidase (TPO) antibody assay; results were not returned for clinical management. At 1 and 5 years after delivery, participants were asked whether they had either been diagnosed with or were being treated for a thyroid condition. Maternal serum was collected at these visits and thyroid function measured. Subsequent overt hypothyroidism was defined as TSH ≥4.0 mU/L with fT4 <0.86 ng/dL. Results: Data for 1- and 5-year follow-up were available in 307 of the 338 participants with SH and 229 of the 261 with HT. Subsequent hypothyroidism was more common both at year 1 (13.4% vs. 3.1%, p < 0.001) and year 5 (15.6% vs. 2.6%, p < 0.001) for participants with SH compared with those with HT. This progression was more common in individuals with TSH values >10 mIU/mL. Baseline TPO level >50 IU/mL in participants with SH was associated with higher rates of hypothyroidism at year 1 (26.7% vs. 6.5%, odds ratio [OR] = 5.3 [confidence interval (CI) 2.6-10.7]) and year 5 (30.5% vs. 7.5%, OR = 5.4 [CI: 2.8-10.6]) compared with those with TPO levels ≤50 IU/mL. For participants with HT, no differences in overt hypothyroidism were seen at 1 year related to baseline TPO level >50 IU/mL (1/10 (10%) vs. 6/218 (2.8%), OR = 3.9 [CI: 0.43-36.1]), but more participants with TPO levels >50 IU/mL developed hypothyroidism by year 5 (2/10 (20%) vs. 4/218 (1.8%), OR = 13.4 [CI: 2.1-84.1]). Conclusion: SH is associated with higher rates of overt hypothyroidism or thyroid replacement therapy within 5 years of delivery than is HT when these conditions are diagnosed in the first half of pregnancy.
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- 2024
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36. Comparing population-based fetal growth standards in a US cohort.
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Gleason JL, Reddy UM, Chen Z, Grobman WA, Wapner RJ, Steller JG, Simhan H, Scifres CM, Blue N, Parry S, and Grantz KL
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- Humans, Female, Pregnancy, United States, Adult, Infant, Newborn, Cohort Studies, Infant, Small for Gestational Age, Growth Charts, Fetal Macrosomia epidemiology, Gestational Age, Young Adult, Fetal Growth Retardation diagnostic imaging, Fetal Weight, Fetal Development physiology, Ultrasonography, Prenatal
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Background: No fetal growth standard is currently endorsed for universal use in the United States. Newer standards improve upon the methodologic limitations of older studies; however, before adopting into practice, it is important to know how recent standards perform at identifying fetal undergrowth or overgrowth and at predicting subsequent neonatal morbidity or mortality in US populations., Objective: To compare classification of estimated fetal weight that is <5th or 10th percentile or >90th percentile by 6 population-based fetal growth standards and the ability of these standards to predict a composite of neonatal morbidity and mortality., Study Design: We used data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be cohort, which recruited nulliparous women in the first trimester at 8 US clinical centers (2010-2014). Estimated fetal weight was obtained from ultrasounds at 16 to 21 and 22 to 29 weeks of gestation (N=9534 women). We calculated rates of fetal growth restriction (estimated fetal weight <5th and 10th percentiles; fetal growth restriction<5 and fetal growth restriction<10) and estimated fetal weight >90th percentile (estimated fetal weight>90) from 3 large prospective fetal growth cohorts with similar rigorous methodologies: INTERGROWTH-21, World Health Organization-sex-specific and combined, Eunice Kennedy Shriver National Institute of Child Health and Human Development race-ethnic-specific and unified, and the historic Hadlock reference. To determine whether differential classification of fetal growth restriction or estimated fetal weight >90 among standards was clinically meaningful, we then compared area under the curve and sensitivity of each standard to predict small for gestational age or large for gestational age at birth, composite perinatal morbidity and mortality alone, and small for gestational age or large for gestational age with composite perinatal morbidity and mortality., Results: The standards classified different proportions of fetal growth restriction and estimated fetal weight>90 for ultrasounds at 16 to 21 (visit 2) and 22 to 29 (visit 3) weeks of gestation. At visit 2, the Eunice Kennedy Shriver National Institute of Child Health and Human Development race-ethnic-specific, World Health Organization sex-specific and World Health Organization-combined identified similar rates of fetal growth restriction<10 (8.4%-8.5%) with the other 2 having lower rates, whereas Eunice Kennedy Shriver National Institute of Child Health and Human Development race-ethnic-specific identified the highest rate of fetal growth restriction<5 (5.0%) compared with the other references. At visit 3, World Health Organization sex-specific classified 9.2% of fetuses as fetal growth restriction<10, whereas the other 5 classified a lower proportion as follows: World Health Organization-combined (8.4%), Eunice Kennedy Shriver National Institute of Child Health and Human Development race-ethnic-specific (7.7%), INTERGROWTH (6.2%), Hadlock (6.1%), and Eunice Kennedy Shriver National Institute of Child Health and Human Development unified (5.1%). INTERGROWTH classified the highest (21.3%) as estimated fetal weight>90 whereas Hadlock classified the lowest (8.3%). When predicting composite perinatal morbidity and mortality in the setting of early-onset fetal growth restriction, World Health Organization had the highest area under the curve of 0.53 (95% confidence interval, 0.51-0.53) for fetal growth restriction<10 at 22 to 29 weeks of gestation, but the areas under the curve were similar among standards (0.52). Sensitivity was generally low across standards (22.7%-29.1%). When predicting small for gestational age birthweight with composite neonatal morbidity or mortality, for fetal growth restriction<10 at 22 to 29 weeks of gestation, World Health Organization sex-specific had the highest area under the curve (0.64; 95% confidence interval, 0.60-0.67) and INTERGROWTH had the lowest (area under the curve=0.58; 95% confidence interval 0.55-0.62), though all standards had low sensitivity (7.0%-9.6%)., Conclusion: Despite classifying different proportions of fetuses as fetal growth restriction or estimated fetal weight>90, all standards performed similarly in predicting perinatal morbidity and mortality. Classification of different percentages of fetuses as fetal growth restriction or estimated fetal weight>90 among references may have clinical implications in the management of pregnancies, such as increased antenatal monitoring for fetal growth restriction or cesarean delivery for suspected large for gestational age. Our findings highlight the importance of knowing how standards perform in local populations, but more research is needed to determine if any standard performs better at identifying the risk of morbidity or mortality., (Published by Elsevier Inc.)
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- 2024
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37. Large-Scale Proteomics in Early Pregnancy and Hypertensive Disorders of Pregnancy.
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Greenland P, Segal MR, McNeil RB, Parker CB, Pemberton VL, Grobman WA, Silver RM, Simhan HN, Saade GR, Ganz P, Mehta P, Catov JM, Bairey Merz CN, Varagic J, Khan SS, Parry S, Reddy UM, Mercer BM, Wapner RJ, and Haas DM
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- Humans, Pregnancy, Female, Adult, Case-Control Studies, Pre-Eclampsia blood, Pre-Eclampsia diagnosis, Biomarkers blood, Predictive Value of Tests, Hypertension, Pregnancy-Induced blood, Hypertension, Pregnancy-Induced diagnosis, Proteomics methods, Pregnancy Trimester, First blood
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Importance: There is no consensus regarding the best method for prediction of hypertensive disorders of pregnancy (HDP), including gestational hypertension and preeclampsia., Objective: To determine predictive ability in early pregnancy of large-scale proteomics for prediction of HDP., Design, Setting, and Participants: This was a nested case-control study, conducted in 2022 to 2023, using clinical data and plasma samples collected between 2010 and 2013 during the first trimester, with follow-up until pregnancy outcome. This multicenter observational study took place at 8 academic medical centers in the US. Nulliparous individuals during first-trimester clinical visits were included. Participants with HDP were selected as cases; controls were selected from those who delivered at or after 37 weeks without any HDP, preterm birth, or small-for-gestational-age infant. Age, self-reported race and ethnicity, body mass index, diabetes, health insurance, and fetal sex were available covariates., Exposures: Proteomics using an aptamer-based assay that included 6481 unique human proteins was performed on stored plasma. Covariates were used in predictive models., Main Outcomes and Measures: Prediction models were developed using the elastic net, and analyses were performed on a randomly partitioned training dataset comprising 80% of study participants, with the remaining 20% used as an independent testing dataset. Primary measure of predictive performance was area under the receiver operating characteristic curve (AUC)., Results: This study included 753 HDP cases and 1097 controls with a mean (SD) age of 26.9 (5.5) years. Maternal race and ethnicity were 51 Asian (2.8%), 275 non-Hispanic Black (14.9%), 275 Hispanic (14.9%), 1161 non-Hispanic White (62.8% ), and 88 recorded as other (4.8%), which included those who did not identify according to these designations. The elastic net model, allowing for forced inclusion of prespecified covariates, was used to adjust protein-based models for clinical and demographic variables. Under this approach, no proteins were selected to augment the clinical and demographic covariates. The predictive performance of the resulting model was modest, with a training set AUC of 0.64 (95% CI, 0.61-0.67) and a test set AUC of 0.62 (95% CI, 0.56-0.68). Further adjustment for study site yielded only minimal changes in AUCs., Conclusions and Relevance: In this case-control study with detailed clinical data and stored plasma samples available in the first trimester, an aptamer-based proteomics panel did not meaningfully add to predictive utility over and above clinical and demographic factors that are routinely available.
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- 2024
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38. Optimal Timing of Delivery for Pregnant Individuals With Mild Chronic Hypertension.
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Metz TD, Kuo HC, Harper L, Sibai B, Longo S, Saade GR, Dugoff L, Aagaard K, Boggess K, Lawrence K, Hughes BL, Bell J, Edwards RK, Gibson KS, Haas DM, Plante L, Casey B, Esplin S, Hoffman MK, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Chang E, Quiñones J, Galis ZS, Ambalavanan N, Sinkey RG, Szychowski JM, and Tita ATN
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- Humans, Female, Pregnancy, Adult, Infant, Newborn, Delivery, Obstetric, Pregnancy Complications, Cardiovascular therapy, Pregnancy Outcome, Time Factors, Cesarean Section statistics & numerical data, Chronic Disease, Young Adult, Gestational Age, Hypertension
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Objective: To investigate the optimal gestational age to deliver pregnant people with chronic hypertension to improve perinatal outcomes., Methods: We conducted a planned secondary analysis of a randomized controlled trial of chronic hypertension treatment to different blood pressure goals. Participants with term, singleton gestations were included. Those with fetal anomalies and those with a diagnosis of preeclampsia before 37 weeks of gestation were excluded. The primary maternal composite outcome included death, serious morbidity (heart failure, stroke, encephalopathy, myocardial infarction, pulmonary edema, intensive care unit admission, intubation, renal failure), preeclampsia with severe features, hemorrhage requiring blood transfusion, or abruption. The primary neonatal outcome included fetal or neonatal death, respiratory support beyond oxygen mask, Apgar score less than 3 at 5 minutes, neonatal seizures, or suspected sepsis. Secondary outcomes included intrapartum cesarean birth, length of stay, neonatal intensive care unit admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn, and hypoglycemia. Those with a planned delivery were compared with those expectantly managed at each gestational week. Adjusted odds ratios (aORs) with 95% CIs are reported., Results: We included 1,417 participants with mild chronic hypertension; 305 (21.5%) with a new diagnosis in pregnancy and 1,112 (78.5%) with known preexisting hypertension. Groups differed by body mass index (BMI) and preexisting diabetes. In adjusted models, there was no association between planned delivery and the primary maternal or neonatal composite outcome in any gestational age week compared with expectant management. Planned delivery at 37 weeks of gestation was associated with RDS (7.9% vs 3.0%, aOR 2.70, 95% CI, 1.40-5.22), and planned delivery at 37 and 38 weeks was associated with neonatal hypoglycemia (19.4% vs 10.7%, aOR 1.97, 95% CI, 1.27-3.08 in week 37; 14.4% vs 7.7%, aOR 1.82, 95% CI, 1.06-3.10 in week 38)., Conclusion: Planned delivery in the early-term period compared with expectant management was not associated with a reduction in adverse maternal outcomes. However, it was associated with increased odds of some neonatal complications. Delivery timing for individuals with mild chronic hypertension should weigh maternal and neonatal outcomes in each gestational week but may be optimized by delivery at 39 weeks., Competing Interests: Financial Disclosure: Torri D. Metz reports personal fees from Pfizer for her role as a medical consultant for a SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for SARS-CoV-2 vaccination in pregnancy study, and grants from Pfizer for role as a site PI for RSV vaccination in pregnancy study outside the submitted work. Sherri Longo reports that UAB received NIH funding for the CHAP trial and Ochsner was one of the sites participating in the trial. Ochsner received a subaward from UAB for participation in the trial. Ochsner is a subsite to UAB, who is in the MFMU network; therefore, they have participated in trials. They have participated in other studies with UAB, including the CSOAP trial. They have collaborated on studies with Tulane and have subawards. Kelly Gibson reports money was paid to her institution from NHLBI, NICHD, and Materna Medical. Lauren Plante reports receiving payment from Cambridge University Press and Taylor & Francis for textbook royalties. She also received an honorarium speaking fee from Monmouth Medical Center. Sean Esplin received payment from Laborie and Nemo Health. Heather Frey and Wendy Kinzler received payment from UpToDate. Todd Rosen's institution received payment from Materna, Inc. and Myriad, Inc. Mary Norton received payment from Luna Genetics. Daniel Skupski received payment from Organon and Cooper Surgical. Leonardo Pereira's institution received payment for a Johnson & Johnson clinical trial. He received payment from Prehevbrio for serving on the data safety monitoring board for hepatitis vaccine in pregnancy. Namasivayam Ambalavanan received payment from Oak Hill Bio and for serving on the advisory board and holding intellectual property with AlveolusBio and Resbiotic. Alan T. N. Tita's institution received payment from Pfizer. Everett Magann received payment from UpToDate for co-authorship of the Ultrasound Assessment of Amniotic Fluid Volume chapter. Lorraine Dugoff reports that money was paid to her institution from Myriad and Natera. Brenna L. Hughes reports receiving funding from UpToDate and Moderna. Eugene Chang reports money was paid to his institution from Roche Diagnostics and Roche. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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39. Post-Acute Sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Infection During Pregnancy.
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Metz TD, Reeder HT, Clifton RG, Flaherman V, Aragon LV, Baucom LC, Beamon CJ, Braverman A, Brown J, Cao T, Chang A, Costantine MM, Dionne JA, Gibson KS, Gross RS, Guerreros E, Habli M, Hadlock J, Han J, Hess R, Hillier L, Hoffman MC, Hoffman MK, Hughes BL, Jia X, Kale M, Katz SD, Laleau V, Mallett G, Mehari A, Mendez-Figueroa H, McComsey GA, Monteiro J, Monzon V, Okumura MJ, Pant D, Pacheco LD, Palatnik A, Palomares KTS, Parry S, Pettker CM, Plunkett BA, Poppas A, Ramsey P, Reddy UM, Rouse DJ, Saade GR, Sandoval GJ, Sciurba F, Simhan HN, Skupski DW, Sowles A, Thorp JM Jr, Tita ATN, Wiegand S, Weiner SJ, Yee LM, Horwitz LI, Foulkes AS, and Jacoby V
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- Humans, Female, Pregnancy, Adult, Risk Factors, United States epidemiology, Prevalence, Cohort Studies, Severity of Illness Index, COVID-19 epidemiology, COVID-19 complications, Pregnancy Complications, Infectious epidemiology, Pregnancy Complications, Infectious virology, SARS-CoV-2, Post-Acute COVID-19 Syndrome
- Abstract
Objective: To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors., Methods: In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC., Results: Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9-10.9%) measured at a median of 10.3 months (interquartile range 6.1-21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12-2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79-3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05-2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00-3.44) were associated with increased prevalence of PASC., Conclusion: The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy., Clinical Trial Registration: ClinicalTrials.gov , NCT05172024., Competing Interests: Financial Disclosure Torri D. Metz is the site PI for a Pfizer study of Paxlovid in pregnancy and was the site PI for a Pfizer study of COVID-19 vaccination in pregnancy. She has received UpToDate royalties for two topics on trial of labor after cesarean. Carmen J. Beamon disclosed receiving payments from Wellcare of North Carolina. Ann Chang's institution received payment from New York University for her efforts on this study. Kelly S. Gibson disclosed that her institution received funding from the NICHD, NHLBI, and Materna. Rachel Hess received payment from Astellas Pharmaceuticals. M. Camile Hoffman disclosed her institution received payment for her expert testimony for one medicolegal trial from Wheeler, Trigg, and Associates (a defense attorneys firm). Her institution also received payment for a disease state presentation on postpartum depression and zuranolone from SAGE/Biogen. Brenna L. Hughes disclosed receiving payments from UpToDate and Moderna. Stuart Katz disclosed payments for providing expert testimony for Venable LLP. Jennifer Hadlock has received funding (paid to institution) for retrospective studies of COVID-19 from Pfizer, Novartis, Janssen, and Gilead. Grace A. McComsey served as an advisor for Gilead and ViiVGlaxoSmithKline. Patrick Ramsey disclosed receiving royalties from UpToDate. His institution was paid by the Texas Collaborative for Healthy Mothers and Babies (TCHMB)—Texas PQC for part of his efforts. Daniel W. Skupski reports receiving payments from Organon, Inc and Cooper Surgical. Alan T.N. Tita disclosed money paid to his institution from Pfizer for his efforts in this study. Andrea Foulkes disclosed receiving past payments from Round Table, Inc. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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40. Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial.
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Smid MC, Clifton RG, Rood K, Srinivas S, Simhan HN, Casey BM, Longo M, Landau R, MacPherson C, Bartholomew A, Sowles A, Reddy UM, Rouse DJ, Bailit JL, Thorp JM Jr, Chauhan SP, Saade GR, Grobman WA, and Macones GA
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- Adult, Female, Humans, Pregnancy, Decision Making, Shared, Pain Management methods, Analgesics, Opioid therapeutic use, Analgesics, Opioid administration & dosage, Cesarean Section, Pain, Postoperative drug therapy
- Abstract
Objective: To test whether an individualized opioid-prescription protocol (IOPP) with a shared decision-making component can be used without compromising postcesarean pain management., Methods: In this multicenter randomized controlled noninferiority trial, we compared IOPP with shared decision making with a fixed quantity of opioid tablets at hospital discharge. We recruited at 31 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Study participants had uncomplicated cesarean births. Follow-up occurred through 12 weeks postdischarge. Individuals with complicated cesarean births or history of opioid use in the pregnancy were excluded. Participants were randomized 1:1 to IOPP with shared decision making or fixed quantity (20 tablets of 5 mg oxycodone). In the IOPP group, we calculated recommended tablet quantity based on opioid use in the 24 hours before discharge. After an educational module and shared decision making, participants selected a quantity of discharge tablets (up to 20). The primary outcome was moderate to severe pain (score 4 or higher [possible range 0-10]) on the BPI (Brief Pain Inventory) at 1 week after discharge. A total sample size of 5,500 participants was planned to assess whether IOPP with shared decision making was not inferior to the fixed quantity of 20 tablets., Results: From September 2020 to March 2022, 18,990 individuals were screened and 5,521 were enrolled (n=2,748 IOPP group, n=2,773 fixed-quantity group). For the primary outcome, IOPP with shared decision making was not inferior to fixed quantity (59.5% vs 60.1%, risk difference 0.67%; 95% CI, -2.03% to 3.37%, noninferiority margin -5.0) and resulted in significantly fewer tablets received (median 14 [interquartile range 4-20] vs 20, P <.001) through 90 days postpartum., Conclusion: Compared with fixed quantity, IOPP with shared decision making was noninferior for outpatient postcesarean analgesia at 1 week postdischarge and resulted in fewer prescribed opioid tablets at discharge., Clinical Trial Registration: ClinicalTrials.gov, NCT04296396., Competing Interests: Financial Disclosure Unrelated to this work, Marcela C. Smid reports that she serves as a consultant for Gilead Science Inc and Alydia/Organon. Her institution receives research funding from both organizations. Rebecca Clifton reports payment from the University of Arkansas for Medical Sciences for DSMB reviews. Sindhu Srinivas reports receiving payments from Goodall, Decries, Leech & Dawn, LLP, and Huff Powell Bailey. Ruth Landau reports receiving payments from PACIRA Biosciences and Regional Anesthesia and Pain Medicine. Cora MacPherson reports receiving payments from PCORI and Natera. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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41. Restless legs syndrome and adverse perinatal outcomes.
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Friedlander R, Huang X, Kim M, Zee PC, Khan SS, Greenland P, Facco FL, Chung JH, Grobman WA, Haas DM, McNeil RB, Mercer BM, Reddy UM, Saade GR, Silver RM, Wiener LE, and Yee LM
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- Humans, Pregnancy, Female, Infant, Newborn, Adult, Restless Legs Syndrome diagnosis, Restless Legs Syndrome epidemiology, Restless Legs Syndrome etiology, Pregnancy Complications epidemiology, Pregnancy Complications diagnosis, Pregnancy Outcome epidemiology
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- 2024
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42. Pregnancy Outcomes in Women Who Developed Elevated Blood Pressure and Stage I Hypertension after 20 Weeks, Gestation.
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Woolcock H, Parra N, Zhang Y, Reddy UM, Bello NA, Miller E, and Booker WA
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- Humans, Female, Pregnancy, Adult, Prospective Studies, Hypertension, Pregnancy-Induced epidemiology, Blood Pressure, Pregnancy Trimester, Second, Gestational Age, Premature Birth epidemiology, Logistic Models, Young Adult, Hypertension epidemiology, Cesarean Section statistics & numerical data, Abruptio Placentae epidemiology, Pregnancy Complications, Cardiovascular, Pregnancy Outcome
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Objective: The American College of Obstetrics threshold for hypertension (≥140/90 mm Hg) differs from those of the American College of Cardiology (ACC) and the American Heart Association (AHA). It is unknown if ACC/AHA hypertension levels are associated with adverse pregnancy outcomes (APOs) after 20 weeks gestation. The purpose of this study is to analyze APOs in women with blood pressure (BP) in the elevated or stage 1 range after 20 weeks gestation., Study Design: This was a secondary analysis of the nuMoM2b prospective cohort study of 10,038 nulliparous, singleton pregnancies between 2010 and 2014. BP was measured at three visits during the pregnancy using a standard protocol. Women without medical comorbidities, with normal BP by ACC/AHA guidelines (systolic BP [SBP] < 120 and diastolic BP [DBP] < 80 mm Hg) up to 22 weeks, were included. Exposure was BP between 22 and 29 weeks gestation: normal (SBP < 120 and DBP < 80 mm Hg), elevated (SBP: 120-129 and DBP < 80 mm Hg), and stage 1 (SBP: 130-139 or DBP: 80-89 mm Hg). The primary outcome was hypertensive disorder of pregnancy (HDP) at delivery. Secondary outcomes included fetal growth restriction (FGR), placental abruption, preterm delivery, and cesarean delivery. Multivariable-adjusted odds ratio (aORs) and 95% confidence intervals (CIs) were estimated using logistic regression models., Results: Of 4,460 patients that met inclusion criteria, 3,832 (85.9%) had BP in the normal range, 408 (9.1%) in elevated, and 220 (4.9%) in stage 1 range between 22 and 29 weeks. The likelihood of HDP was significantly higher in women with elevated BP (aOR: 1.71, 95%CI: 1.18,2.48), and stage 1 BP (aOR: 2.79, 95%CI: 1.84,4.23) compared to normal BP ( p < 0.001). Stage 1 BP had twice odds of FGR (aOR: 2.33, 95%CI: 1.22,4.47) and elevated BP had three times odds of placental abruption (aOR: 3.03; 95%CI: 1.24,7.39)., Conclusion: Elevated or stage 1 BP >20 weeks of pregnancy are associated with HDP, FGR, and placental abruption., Key Points: · Elevated and stage 1 BP increases risk for HDP.. · Elevated BP increases risk for placental abruption.. · Stage 1 BP increases risk for FGR.., Competing Interests: None declared., (Thieme. All rights reserved.)
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- 2024
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43. Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension.
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Moore MD, Kuo HC, Sinkey RG, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey HA, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Chang E, Osmundson S, Quiñones JN, Leach J, Sanusi A, Galis ZS, Harper L, Ambalavanan N, Szychowski JM, and Tita ATN
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- Humans, Female, Pregnancy, Infant, Newborn, Adult, Pregnancy Outcome, Arterial Pressure, Hypertension, Pregnancy-Induced drug therapy, Antihypertensive Agents therapeutic use, Hypertension drug therapy, Pregnancy Complications, Cardiovascular
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Objective: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial., Methods: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated., Results: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations., Conclusion: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits., Clinical Trial Registration: ClinicalTrials.gov , NCT02299414., Competing Interests: Financial Disclosure Rodney K. Edwards' institution received grants from the Oklahoma Center for Advancement of Science and Technology for a pilot study related to postcesarean opioids, and from the NIH through Oklahoma CTR for a pilot trial on warming preterm infants during delayed cord clamping, a Presbyterian Health Foundation Team Science grant for a pilot trial evaluating effect of omega-3 fatty acid supplementation on maternal triglycerides and fetal growth, an NIH grant to evaluate changes in atherogenic apolipoproteins with immediate prepregnancy intervention and whether they were maintained during pregnancy, a grant from Cepheid for clinical evaluation of the Xpert Xpress GBS test using vaginal/rectal dual swabs collected intrapartum, and an NIH grant for a multicenter RCT evaluating intensive glycemic targets in overweight and obese women with GDM. He has a pending NIH grant for a multicenter RCT evaluating prophylactic antibiotics for inductions of labor in nulliparous women with obesity at term. Dr. Edwards served as an expert witness in a case regarding a malpractice claim. Kelly S. Gibson's institution received funding for the Materna Medical research study (EASE). She received payment from the NIH for serving on the RADX grant review committee. She has been a speaker at an ACOG-AIM webinar and received a Ohio State AIM grant for hypertension treatment. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Pfizer, as she has been a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial, a COVID-19 vaccine trial in pregnancy, and pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19 (institution received money to conduct studies). Sean Esplin received payment from Laborie. Anna Palatnik received payment from the American Heart Association career development award and from NHLBI HL165013 to evaluate intensive postpartum antihypertensive treatment following gestational hypertension or preeclampsia. Mary E. Norton received payment from Luna Genetics. Leonardo Pereira's institution received payment from Johnson & Johnson/Janssen pharmaceuticals to support a clinical trial in alloimmunized patients. Everett F. Magann received a royalty as an author of the UpToDate chapter on ultrasound estimate of amniotic fluid volume. Eugene Chang's institution received payment from Roche Diagnostics. Alan T.N. Tita's institution received payment from Pfizer. Sherri Longo acknowledges the financial support received for the Prospect study and other NIH-funded studies including CHAP maternal follow-up and CSOAP follow-up. She is also an investigator for the Moms on the Bayou research project with Tulane University and is receiving funding from the NIH Maternal Health Research Center of Excellence awarded to a collaborative effort between Tulane University, Ochsner Health, and RHI. Todd Rosen acknowledges the financial support received as a co-investigator from Materna Medical Inc to evaluate the safety and effectiveness of the Materna Prep Device; NEIHS/HIN for the Ambient Air Pollution, Weather, and Placental Abruption (APWA) study; NIH/NICHD for The Genomic Architecture of Pregnancy Loss study and Multicenter Maternal-Fetal Medicine Unit Research Network—MFMU Clinical Center (TAC); NIH/NHLBI for Pregnancy as a Window to the Future study (a CHAP maternal follow-up study) and for Cardiovascular Health After Placental Abruption study; and as a principal investigator for Sulfasalazine to Prevent Preterm Birth, funded by the Hudson Shea Foundation and The Perinatal Research Consortium. Daniel Skupski's institution received payment from Pfizer, as he served as a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial (institution received money to conduct study). His institution also received payment for her to serve as a site PI for a COVID-19 vaccination trial in pregnancy. Dr. Skupski is also a paid consultant for the Organon company in relation to a medical device (Fetal Pillow) used to manage cesarean deliveries performed during the second stage of labor. Rachel Sinkey received funding paid to her institution from the NIH and the American Heart Association. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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44. Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension.
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Sanusi AA, Leach J, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Kuo HC, Sinkey RG, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Chang E, Osmundson S, Quinones J, Szychowski JM, and Tita ATN
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- Humans, Pregnancy, Female, Adult, Infant, Newborn, Pregnancy Complications, Cardiovascular drug therapy, Hypertension, Pregnancy-Induced drug therapy, Administration, Oral, Infant, Small for Gestational Age, Pre-Eclampsia drug therapy, Chronic Disease, Labetalol administration & dosage, Labetalol adverse effects, Labetalol therapeutic use, Nifedipine administration & dosage, Nifedipine adverse effects, Nifedipine therapeutic use, Antihypertensive Agents administration & dosage, Antihypertensive Agents adverse effects, Antihypertensive Agents therapeutic use, Pregnancy Outcome, Hypertension drug therapy
- Abstract
Objective: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial., Methods: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding., Results: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine., Conclusion: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy., Clinical Trial Registration: ClinicalTrials.gov, NCT02299414., Competing Interests: Financial Disclosure Brenna L. Hughes reports receiving payment from UpToDate. Rodney K. Edwards' institution received payment from the Oklahoma Center for Advancement of Science and Technology and the Presbyterian Health Foundation. He received payment from the NIH through Oklahoma CTR grant for a pilot trial on warming preterm infants during delayed cord clamping. He received a Presbyterian Health Foundation grant for a pilot trial on omega-3 fatty acid supplementation effects on maternal triglycerides and fetal growth. He received an NIH grant for evaluation of atherogenic lipoproteins changes with immediate prepregnancy intervention and whether they were maintained during pregnancy. He received a grant from Cepheid for the clinical evaluation of the Xpert Xpress GBS test using vaginal/rectal swabs collected intrapartum. He was awarded an Oklahoma State DOH contract for support for patient-centered, comprehensive pregnancy care for women with substance use disorders. He received an NIH grant for a multicenter RCT of intensive glycemic targets in women with overweight and obesity with GDM. Lastly, he has a pending NIH grant for a multicenter RCT of prophylactic antibiotics for induction of labor in women with obesity. He has served on an expert witness case regarding a medical malpractice claim. Kelly S. Gibson's institution received an NHCID-MFMU network grant and Materna Medical research support (EASE). She received payment from NIH as a RADx grant reviewer and was an Ohio AIM grant recipient as an AIM webinar speaker. Rachel Sinkey received funding paid to her institution from the NIH and the American Heart Association. Kelly S. Gibson reports her institution received an NHCID-MFMU network grant and Materna Medical research support (EASE). She received payment as a NIH-RADx grant reviewer. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Pfizer, as she has been a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial (institution received money to conduct study). Her institution also received payment for her to serve as a site PI for a COVID-19 vaccination trial in pregnancy. She has received payment from Pfizer as a site PI for a pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19. Sean Esplin received payment from Laborie. Mary E. Norton received payment from Luna Genetics. Daniel Skupski received payment from Organon and Cooper Surgical. Leonardo Pereira's institution received payment from Johnson & Johnson/Janssen Pharmaceuticals for an FDA trial on alloimmunization management. Everett F. Magann is a co-author on and UpToDate chapter on amniotic fluid volume assessment. Heather Frey also received royalties for contributions to UpToDate on the topic of uterine rupture. Alan T.N. Tita's institution received funding from Pfizer. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Pfizer, as she has been a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial, a COVID-19 vaccine trial in pregnancy, and pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19 (institution received money to conduct studies). Kara K. Hoppe's institution received an NIH grant for a multicenter RCT of remote blood pressure monitoring with health coaching versus standard of care, HHS funding for a hypertension challenge initiative, Marani to study implementation of their remote patient monitoring platform for hypertensive patients in pregnancy and postpartum. Additionally, she received payment for the NIH as a grant reviewer and WisPQC for providing physician leadership for the state quality initiative on hypertension in pregnancy. Eugene Chang received payment from Roche diagnostics for research on sflt-1/plgf. Sherri Longo acknowledges the financial support received for the Prospect study and other NIH-funded studies including CHAP maternal follow-up and CSOAP follow-up. She is also an investigator for the Moms on the Bayou research project with Tulane University and is receiving funding from the NIH Maternal Health Research Center of Excellence awarded to a collaborative effort between Tulane University, Ochsner Health, and RHI. Alan T.N. Tita's institution received funding from Pfizer. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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45. Comparison of Cesarean Deliveries in a Multicenter U.S. Cohort Using the 10-Group Classification System.
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Pasko DN, McGee P, Grobman WA, Bailit JL, Reddy UM, Wapner RJ, Varner MW, Thorp JM Jr, Caritis SN, Prasad M, Saade GR, Sorokin Y, Rouse DJ, and Tolosa JE
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- Humans, Female, Pregnancy, United States, Adult, Logistic Models, Cohort Studies, Young Adult, Hospitals statistics & numerical data, Parity, Cesarean Section statistics & numerical data, Cesarean Section classification
- Abstract
Objective: We sought to (1) use the Robson 10-Group Classification System (TGCS), which classifies deliveries into 10 mutually exclusive groups, to characterize the groups that are primary contributors to cesarean delivery frequencies, (2) describe inter-hospital variations in cesarean delivery frequencies, and (3) evaluate the contribution of patient characteristics by TGCS group to hospital variation in cesarean delivery frequencies., Study Design: This was a secondary analysis of an observational cohort of 115,502 deliveries from 25 hospitals between 2008 and 2011. The TGCS was applied to the cohort and each hospital. We identified and compared the TGCS groups with the greatest relative contributions to cohort and hospital cesarean delivery frequencies. We assessed variation in hospital cesarean deliveries attributable to patient characteristics within TGCS groups using hierarchical logistic regression., Results: A total of 115,211 patients were classifiable in the TGCS (99.7%). The cohort cesarean delivery frequency was 31.4% (hospital range: 19.1-39.3%). Term singletons in vertex presentation with a prior cesarean delivery (group 5) were the greatest relative contributor to cohort (34.8%) and hospital cesarean delivery frequencies (median: 33.6%; range: 23.8-45.5%). Nulliparous term singletons in vertex (NTSV) presentation (groups 1 [spontaneous labor] and 2 [induced or absent labor]: 28.9%), term singletons in vertex presentation with a prior cesarean delivery (group 5: 34.8%), and preterm singletons in vertex presentation (group 10: 9.8%) contributed to 73.2% of the relative cesarean delivery frequency for the cohort and were correlated with hospital cesarean delivery frequencies (Spearman's rho = 0.96). Differences in patient characteristics accounted for 34.1% of hospital-level cesarean delivery variation in group 2., Conclusion: The TGCS highlights the contribution of NTSV presentation to cesarean delivery frequencies and the impact of patient characteristics on hospital-level variation in cesarean deliveries among nulliparous patients with induced or absent labor., Key Points: · We report on the cesarean delivery frequencies in a multicenter U.S., Cohort: . · NTSV gestations (groups 1 and 2) are a primary driver of cesarean deliveries.. · Patient characteristics contributed most to hospital variation in cesarean deliveries in group 2.., Competing Interests: None declared., (Thieme. All rights reserved.)
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- 2024
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46. Induction of labor vs expectant management among low-risk patients with 1 prior cesarean delivery.
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Ukoha EP, Wen T, and Reddy UM
- Abstract
Background: Studies that have compared induction of labor in individuals with 1 prior cesarean delivery to expectant management have shown conflicting results., Objective: To determine the association between clinical outcomes and induction of labor at 39 weeks in a national sample of otherwise low-risk patients with 1 prior cesarean delivery., Study Design: This cross-sectional study analyzed 2016 to 2021 US Vital Statistics birth certificate data. Individuals with vertex, singleton pregnancies, and 1 prior cesarean delivery were included. Patients with prior vaginal deliveries, delivery before 39 weeks 0 days or after 42 weeks 6 days of gestation, and medical comorbidities were excluded. The primary exposure of interest was induction of labor at 39 weeks 0 days to 39 weeks 6 days compared to expectant management with delivery from 40 weeks 0 days to 42 weeks 6 days. The primary outcome was vaginal delivery. The main secondary outcomes were separate maternal and neonatal morbidity composites. The maternal morbidity composite included uterine rupture, operative vaginal delivery, peripartum hysterectomy, intensive care unit admission, and transfusion. The neonatal morbidity composite included neonatal intensive care unit admission, Apgar score less than 5 at 5 minutes, immediate ventilation, prolonged ventilation, and seizure or serious neurological dysfunction. Unadjusted and adjusted log binomial regression models accounting for demographic variables and the exposure of interest (induction vs expectant management) were performed. Results are presented as unadjusted and adjusted risk ratios with 95% confidence intervals., Results: From 2016 to 2021, a total of 198,797 individuals with vertex, singleton pregnancies, and 1 prior cesarean were included in the primary analysis. Of these individuals, 25,915 (13.0%) underwent induction of labor from 39 weeks 0 days to 39 weeks 6 days and 172,882 (87.0%) were expectantly managed with deliveries between 40 weeks 0 days and 42 weeks 6 days. In adjusted analyses, patients induced at 39 weeks were more likely to have a vaginal delivery when compared to those expectantly managed (38.0% vs 31.8%; adjusted risk ratio 1.32, 95% confidence interval 1.28, 1.36). Among those who had vaginal deliveries, induction of labor was associated with increased likelihood of operative vaginal delivery (11.1% vs 10.0; adjusted risk ratio 1.15, 95% confidence interval 1.07, 1.24). The maternal morbidity composite occurred in 0.9% of individuals in both the induction and expectant management groups (adjusted risk ratio 0.92, 95% confidence interval 0.79, 1.06). The rates of uterine rupture (0.3%), peripartum hysterectomy (0.04% vs 0.05%), and intensive care unit admission (0.1% vs 0.2%) were all relatively low and did not differ significantly between groups. There was also no significant difference in the neonatal morbidity composite between the induction and expectant management groups (7.3% vs 6.7%; adjusted risk ratio 1.04, 95% confidence interval 0.98, 1.09)., Conclusion: When compared to expectant management, elective induction of labor at 39 weeks in low-risk patients with 1 prior cesarean delivery was associated with a significantly higher likelihood of vaginal delivery with no difference in composite maternal and neonatal morbidity outcomes. Prospective studies are needed to better elucidate the risks and benefits of induction of labor in this patient population., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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47. Adverse Pregnancy Outcomes and Predicted 30-Year Risk of Maternal Cardiovascular Disease 2-7 Years After Delivery.
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Venkatesh KK, Khan SS, Yee LM, Wu J, McNeil R, Greenland P, Chung JH, Levine LD, Simhan HN, Catov J, Scifres C, Reddy UM, Pemberton VL, Saade G, Bairey Merz CN, and Grobman WA
- Subjects
- Humans, Female, Pregnancy, Adult, Prospective Studies, Premature Birth epidemiology, Cardiovascular Diseases epidemiology, Cardiovascular Diseases etiology, Longitudinal Studies, Hypertension, Pregnancy-Induced epidemiology, Diabetes, Gestational epidemiology, Risk Factors, Infant, Newborn, Risk Assessment, Pregnancy Outcome epidemiology
- Abstract
Objective: To determine whether adverse pregnancy outcomes are associated with a higher predicted 30-year risk of atherosclerotic cardiovascular disease (CVD; ie, coronary artery disease or stroke)., Methods: This was a secondary analysis of the prospective Nulliparous Pregnancy Outcomes Study-Monitoring Mothers-to-Be Heart Health Study longitudinal cohort. The exposures were adverse pregnancy outcomes during the first pregnancy (ie, gestational diabetes mellitus [GDM], hypertensive disorder of pregnancy, preterm birth, and small- and large-for-gestational-age [SGA, LGA] birth weight) modeled individually and secondarily as the cumulative number of adverse pregnancy outcomes (ie, none, one, two or more). The outcome was the 30-year risk of atherosclerotic CVD predicted with the Framingham Risk Score assessed at 2-7 years after delivery. Risk was measured both continuously in increments of 1% and categorically, with high predicted risk defined as a predicted risk of atherosclerotic CVD of 10% or more. Linear regression and modified Poisson models were adjusted for baseline covariates., Results: Among 4,273 individuals who were assessed at a median of 3.1 years after delivery (interquartile range 2.5-3.7), the median predicted 30-year atherosclerotic CVD risk was 2.2% (interquartile range 1.4-3.4), and 1.8% had high predicted risk. Individuals with GDM (least mean square 5.93 vs 4.19, adjusted β=1.45, 95% CI, 1.14-1.75), hypertensive disorder of pregnancy (4.95 vs 4.22, adjusted β=0.49, 95% CI, 0.31-0.68), and preterm birth (4.81 vs 4.27, adjusted β=0.47, 95% CI, 0.24-0.70) were more likely to have a higher absolute risk of atherosclerotic CVD. Similarly, individuals with GDM (8.7% vs 1.4%, adjusted risk ratio [RR] 2.02, 95% CI, 1.14-3.59), hypertensive disorder of pregnancy (4.4% vs 1.4%, adjusted RR 1.91, 95% CI, 1.17-3.13), and preterm birth (5.0% vs 1.5%, adjusted RR 2.26, 95% CI, 1.30-3.93) were more likely to have a high predicted risk of atherosclerotic CVD. A greater number of adverse pregnancy outcomes within the first birth was associated with progressively greater risks, including per 1% atherosclerotic CVD risk (one adverse pregnancy outcome: 4.86 vs 4.09, adjusted β=0.59, 95% CI, 0.43-0.75; two or more adverse pregnancy outcomes: 5.51 vs 4.09, adjusted β=1.16, 95% CI, 0.82-1.50), and a high predicted risk of atherosclerotic CVD (one adverse pregnancy outcome: 3.8% vs 1.0%, adjusted RR 2.33, 95% CI, 1.40-3.88; two or more adverse pregnancy outcomes: 8.7 vs 1.0%, RR 3.43, 95% CI, 1.74-6.74). Small and large for gestational age were not consistently associated with a higher atherosclerotic CVD risk., Conclusion: Individuals who experienced adverse pregnancy outcomes in their first birth were more likely to have a higher predicted 30-year risk of CVD measured at 2-7 years after delivery. The magnitude of risk was higher with a greater number of adverse pregnancy outcomes experienced., Competing Interests: Financial Disclosure Philip Greenland reports receiving payment from the University of Pennsylvania, Wake Forest University, and Boston University for serving on their advisory boards. He has also been an editor for JAMA . The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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48. Genetic Associations with Placental Proteins in Maternal Serum Identify Biomarkers for Hypertension in Pregnancy.
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Yan Q, Blue NR, Truong B, Zhang Y, Guerrero RF, Liu N, Honigberg MC, Parry S, McNeil RB, Simhan HN, Chung J, Mercer BM, Grobman WA, Silver R, Greenland P, Saade GR, Reddy UM, Wapner RJ, and Haas DM
- Abstract
Background: Preeclampsia is a complex syndrome that accounts for considerable maternal and perinatal morbidity and mortality. Despite its prevalence, no effective disease-modifying therapies are available. Maternal serum placenta-derived proteins have been in longstanding use as markers of risk for aneuploidy and placental dysfunction, but whether they have a causal contribution to preeclampsia is unknown., Objective: We aimed to investigate the genetic regulation of serum placental proteins in early pregnancy and their potential causal links with preeclampsia and gestational hypertension., Study Design: This study used a nested case-control design with nulliparous women enrolled in the nuMoM2b study from eight clinical sites across the United States between 2010 and 2013. The first- and second-trimester serum samples were collected, and nine proteins were measured, including vascular endothelial growth factor (VEGF), placental growth factor, endoglin, soluble fms-like tyrosine kinase-1 (sFlt-1), a disintegrin and metalloproteinase domain-containing protein 12 (ADAM-12), pregnancy-associated plasma protein A, free beta-human chorionic gonadotropin, inhibin A, and alpha-fetoprotein. This study used genome-wide association studies to discern genetic influences on these protein levels, treating proteins as outcomes. Furthermore, Mendelian randomization was used to evaluate the causal effects of these proteins on preeclampsia and gestational hypertension, and their further causal relationship with long-term hypertension, treating proteins as exposures., Results: A total of 2,352 participants were analyzed. We discovered significant associations between the pregnancy zone protein locus and concentrations of ADAM-12 (rs6487735, P= 3.03×10
-22 ), as well as between the vascular endothelial growth factor A locus and concentrations of both VEGF (rs6921438, P= 7.94×10-30 ) and sFlt-1 (rs4349809, P= 2.89×10-12 ). Our Mendelian randomization analyses suggested a potential causal association between first-trimester ADAM-12 levels and gestational hypertension (odds ratio=0.78, P= 8.6×10-4 ). We also found evidence for a potential causal effect of preeclampsia (odds ratio=1.75, P =8.3×10-3 ) and gestational hypertension (odds ratio=1.84, P =4.7×10-3 ) during the index pregnancy on the onset of hypertension 2-7 years later. The additional mediation analysis indicated that the impact of ADAM-12 on postpartum hypertension could be explained in part by its indirect effect through gestational hypertension (mediated effect=-0.15, P= 0.03)., Conclusions: Our study discovered significant genetic associations with placental proteins ADAM-12, VEGF, and sFlt-1, offering insights into their regulation during pregnancy. Mendelian randomization analyses demonstrated evidence of potential causal relationships between the serum levels of placental proteins, particularly ADAM-12, and gestational hypertension, potentially informing future prevention and treatment investigations.- Published
- 2024
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49. A multisite study to develop and validate first trimester, circulating microparticle biomarkers for tiered risk stratification of spontaneous preterm birth in nulliparas.
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Rosenblatt KP, Zhang Z, Doss R, Gurnani PP, Grobman WA, Silver RM, Parry S, Reddy UM, Cao S, and Haas DM
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Background: Despite much research, advances in early prediction of spontaneous preterm birth (sPTB) has been slow. The evolving field of circulating microparticle (CMP) biology may identify novel blood-based, and clinically useful, biomarkers., Objective: To test the ability of a previously identified, 7-marker set of CMP-derived proteins from the first trimester of pregnancy, in the form of an in vitro diagnostic multivariate index assay (IVDMIA), to stratify pregnant patients according to their risk for sPTB., Study Design: We employed a previously validated set of CMP protein biomarkers, utilizing mass spectrometry assays and a nested case-control design in a subset of participants from the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b). We evaluated these biomarkers in the form of an IVDMIA to predict risk for sPTB at different gestational ages. Plasma samples collected at 9- to 13-weeks' gestation were analyzed. The IVDMIA assigned subjects to 1 of 3 sPTB risk categories: low risk (LR), moderate risk (MR), or high risk (HR). Independent validation on a set-aside set confirmed the IVDMIA's performance in risk stratification., Results: Samples from 400 participants from the nuMoM2b cohort were used for the study; of these, 160 delivered<37 weeks and 240 delivered at term. Through Monte Carlo simulation in which the validation results were adjusted based on actual weekly sPTB incidence rates in the nuMoM2b cohort, the IVDMIA stratifications demonstrated statistically significant differences among the risk groups in time-to-event (birth) analysis (P<.0001). The incidence-rate adjusted cumulative risks of sPTB at ≤32 weeks' gestation were 0.4%, 1.6%, and 7.5%, respectively for the LR, MR, and HR groups, respectively. Compared to the LR group, the corresponding risk ratios of the IVDMIA assigned MR and HR group were 4.25 (95% confidence interval [CI] 2.2-7.9) and 19.92 (95% CI 10.4-37.4), respectively., Conclusion: A first trimester CMP protein biomarker panel can be used to stratify risk for sPTB at different gestational ages. Such a multitiered stratification tool could be used to assess risk early in pregnancy to enable timely clinical management and interventions, and, ultimately, to enable the development of tailored care pathways for sPTB prevention., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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50. Socioeconomic disadvantage in pregnancy and postpartum risk of cardiovascular disease.
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Venkatesh KK, Khan SS, Catov J, Wu J, McNeil R, Greenland P, Wu J, Levine LD, Yee LM, Simhan HN, Haas DM, Reddy UM, Saade G, Silver RM, Merz CNB, and Grobman WA
- Abstract
Background: Pregnancy is an educable and actionable life stage to address social determinants of health (SDOH) and lifelong cardiovascular disease (CVD) prevention. However, the link between a risk score that combines multiple neighborhood-level social determinants in pregnancy and the risk of long-term CVD remains to be evaluated., Objective: To examine whether neighborhood-level socioeconomic disadvantage measured by the Area Deprivation Index (ADI) in early pregnancy is associated with a higher 30-year predicted risk of CVD postpartum, as measured by the Framingham Risk Score., Study Design: An analysis of data from the prospective Nulliparous Pregnancy Outcomes Study-Monitoring Mothers-to-Be Heart Health Study longitudinal cohort. Participant home addresses during early pregnancy were geocoded at the Census-block level. The exposure was neighborhood-level socioeconomic disadvantage using the 2015 ADI by tertile (least deprived [T1], reference; most deprived [T3]) measured in the first trimester. Outcomes were the predicted 30-year risks of atherosclerotic cardiovascular disease (ASCVD, composite of fatal and nonfatal coronary heart disease and stroke) and total CVD (composite of ASCVD plus coronary insufficiency, angina pectoris, transient ischemic attack, intermittent claudication, and heart failure) using the Framingham Risk Score measured 2 to 7 years after delivery. These outcomes were assessed as continuous measures of absolute estimated risk in increments of 1%, and, secondarily, as categorical measures with high-risk defined as an estimated probability of CVD ≥10%. Multivariable linear regression and modified Poisson regression models adjusted for baseline age and individual-level social determinants, including health insurance, educational attainment, and household poverty., Results: Among 4309 nulliparous individuals at baseline, the median age was 27 years (interquartile range [IQR]: 23-31) and the median ADI was 43 (IQR: 22-74). At 2 to 7 years postpartum (median: 3.1 years, IQR: 2.5, 3.7), the median 30-year risk of ASCVD was 2.3% (IQR: 1.5, 3.5) and of total CVD was 5.5% (IQR: 3.7, 7.9); 2.2% and 14.3% of individuals had predicted 30-year risk ≥10%, respectively. Individuals living in the highest ADI tertile had a higher predicted risk of 30-year ASCVD % (adjusted ß: 0.41; 95% confidence interval [CI]: 0.19, 0.63) compared with those in the lowest tertile; and those living in the top 2 ADI tertiles had higher absolute risks of 30-year total CVD % (T2: adj. ß: 0.37; 95% CI: 0.03, 0.72; T3: adj. ß: 0.74; 95% CI: 0.36, 1.13). Similarly, individuals living in neighborhoods in the highest ADI tertile were more likely to have a high 30-year predicted risk of ASCVD (adjusted risk ratio [aRR]: 2.21; 95% CI: 1.21, 4.02) and total CVD ≥10% (aRR: 1.35; 95% CI: 1.08, 1.69)., Conclusion: Neighborhood-level socioeconomic disadvantage in early pregnancy was associated with a higher estimated long-term risk of CVD postpartum. Incorporating aggregated SDOH into existing clinical workflows and future research in pregnancy could reduce disparities in maternal cardiovascular health across the lifespan, and requires further study., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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