Search

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.)

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.)

Objective: To develop evidence- and consensus-based clinical practice guidelines for management of high-tone pelvic floor dysfunction (HTPFD). High-tone pelvic floor dysfunction is a neuromuscular disorder of the pelvic floor characterized by non-relaxing pelvic floor muscles, resulting in lower urinary tract and defecatory symptoms, sexual dysfunction, and pelvic pain. Despite affecting 80% of women with chronic pelvic pain, there are no uniformly accepted guidelines to direct the management of these patients., Methods: A Delphi method of consensus development was used, comprising three survey rounds administered anonymously via web-based platform (Qualtrics XM) to national experts in the field of HTPFD recruited through targeted invitation between September and December 2021. Eleven experts participated with backgrounds in urology, urogynecology, minimally invasive gynecology, and pelvic floor physical therapy (PFPT) participated. Panelists were asked to rate their agreement with rated evidence-based statements regarding HTPFD treatment. Statements reaching consensus were used to generate a consensus treatment algorithm., Results: A total of 31 statements were reviewed by group members at the first Delphi round with 10 statements reaching consensus. 28 statements were reposed in the second round with 17 reaching consensus. The putative algorithm met clinical consensus in the third round. There was universal agreement for PFPT as first-line treatment for HTPFD. If satisfactory symptom improvement is reached with PFPT, the patient can be discharged with a home exercise program. If no improvement after PFPT, second-line options include trigger or tender point injections, vaginal muscle relaxants, and cognitive behavioral therapy, all of which can also be used in conjunction with PFPT. Onabotulinumtoxin A injections should be used as third line with symptom assessment after 2-4 weeks. There was universal agreement that sacral neuromodulation is fourth-line intervention. The largest identified barrier to care for these patients is access to PFPT. For patients who cannot access PFPT, experts recommend at-home, guided pelvic floor relaxation, self-massage with vaginal wands, and virtual PFPT visits., Conclusion: A stepwise approach to the treatment of HTPFD is recommended, with patients often necessitating multiple lines of treatment either sequentially or in conjunction. However, PFPT should be offered first line., Competing Interests: Financial Disclosure Michele Torosis is an advisor for Iota Bioscience and Exploramed Development. Kimberly Kenton reports receiving payment from Ethicon for expert witness testimony. Rhonda Kotarinos is a contributor to UpToDate. Erin Carey reports providing expert witness testimony unrelated to this work for McEwan, Martinez, Dukes & Hall, P.A.; BeytinMcLaughlin; Massy & Associates; Wallach; McBrideHall; and Davis Wright Tremaine, LLP. She received payments from Med IQ for providing education on endometriosis. She holds two patents held by UNC remote from commercialization. Neither is licensed and neither is evaluated or considered in this Delphi review. No payment, royalties, or honoraria were received or planned from them in the next 12 months: 1) PCT International PCT/US20/55816, a drug delivery system for vulvodynia symptoms in women; and 2) PCT/US2023/016013, a device for pelvic floor dysfunction in women. She received honoraria for Grand Rounds from LSU (5/2023) and USF (4/2023). She is an International Pelvic Pain Society Immediate past president. H. Henry Lai disclosed money was paid to his institution from the NIH and Metronic. He received payment from Neuspera. He has relationships with Astella, IronWood, BioHaven, Aquinox, Teva, and MicroGenDx. Jerry Lowder reports money was paid to their institution from the NIH-NIDDK. They also received payment as an expert witness. Melanie Meister reports receiving payment from AbbVie, Inc. A. Lenore Ackerman receives grant funding from Medtronic, Inc. and MicrogenDx. Dr. Ackerman is an advisor for AbbVie and Watershed Medical. The other authors did not report any potential conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130-139/80-89 mm Hg and pregnancy outcomes., Methods: We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130-139/80-89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA)., Results: Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130-139/80-89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38-0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA., Conclusion: In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA., Clinical Trial Registration: ClinicalTrials.gov , NCT02299414., Competing Interests: Financial Disclosure Alan T.N. Tita reported money was paid to his institution by Pfizer for his efforts on this study. Torri D. Metz disclosed money was paid to her from UpToDate for two topics on trial of labor after cesarean, and money was paid to her institution from Gestvision as a site PI for a preeclampsia point-of-care test; her institution received money to conduct the study (ended August 2020). She has been a site PI for Pfizer on a phase III RSV vaccine trial, and her institution received money to conduct the study. She has also been a member of the Pfizer medical advisory board (1/15/21) and site PI for a COVID-19 vaccination trial in pregnancy. She has served on the SMFM Board of Directors. Lorraine Dugoff reports money was paid to her institution from Laboratory Holdings, Inc. and Natera, Inc. Brenna L. Hughes reports receiving payment from UpToDate. Mary E. Norton reports receiving payment from the American Board of Obstetrics and Gynecology and Luna Genetics. Daniel Skupski disclosed he is a consultant for Cooper Surgical, Inc, and has received payment from Organon. Namasivayam Ambalayanan reports receiving payment from Resbiotic/AlveolusBio and Shire/Oak Hill Bio. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To estimate the rate of perinatal transmission of hepatitis C virus (HCV) infection, to identify risk factors for perinatal transmission of HCV infection, and to determine the viremic threshold for perinatal transmission., Methods: This was a prospective, multicenter, observational study of pregnant individuals at less than 24 weeks of gestation screened for HCV infection from 2012 to 2018 in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Individuals found to be HCV antibody-positive were followed throughout pregnancy. Children were followed for evidence of perinatal transmission at 2-6 months (HCV RNA testing) and at 18-24 months (HCV RNA and antibody testing) of life. The primary outcome was perinatal transmission, defined as positive test results at either follow-up time point., Results: A total of 109,379 individuals were screened for HCV infection. Of the 1,224 participants who screened positive, 772 (63.1%) enrolled and 432 of those 772 (56.0%) had data available to assess primary outcome. The overall rate of perinatal transmission was 6.0% (26/432, 95% CI 4.0-8.7%). All children with HCV infection were born to individuals with demonstrable viremia. In viremic participants (n=314), the perinatal transmission rate was 8.0% (95% CI 5.2-11.5%). Risk factors for perinatal transmission included HCV RNA greater than 106 international units/mL (adjusted odds ratio [aOR] 8.22, 95% CI 3.16-21.4) and vaginal bleeding reported at any time before delivery (aOR 3.26, 95% CI 1.32-8.03). A viremic threshold for perinatal transmission could not be established., Conclusion: Perinatal transmission of HCV infection was limited to viremic individuals. High viral loads and antepartum bleeding were associated with perinatal transmission., Competing Interests: Financial Disclosure Mona Prasad served on the medical advisory board for Gilead. Brenna Hughes disclosed receiving payment from UpToDate and the Johns Hopkins DSMB. Ana Puga disclosed that she is cochair of the Broward County Perinatal HIV Network (no compensation) and a full-time employee of ViiV Healthcare since 2018. Torri D. Metz disclosed receiving UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Gestvision for her being a site PI for a preeclampsia point-of-care test (institution received money to conduct study [ended August 2020]) and from Pfizer for being a site PI for a Phase III respiratory syncytial virus (RSV) vaccine trial (institution received money to conduct the study). She has been a member of the medical advisory board for Pfizer, a site PI for a COVID-19 vaccination trial, and has served on the Board of Directors for the Society for Maternal-Fetal Medicine. Geeta Swamy reports money was paid to her from GlaxoSmithKline, Pfizer, and WebMD/Medscape. Andrew Wiznia received payment for a consultancy with Janssen Pharmaceuticals, where he has been a chairperson of the Independent Data Safety Monitoring Board. He has also received payment from Merck for a consultancy and protocol development. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the association between maternal and delivery characteristics and self-reported perceived control during childbirth., Methods: A secondary analysis of a multicenter randomized trial was conducted to compare labor induction at 39 weeks of gestation with expectant management in low-risk nulliparous people. Six to 96 hours after delivery, participants who experienced labor completed the Labor Agentry Scale, a validated self-administered questionnaire to ascertain perceived control during childbirth. Scores range from 29 to 203, with higher scores indicating a sense of greater control. Multivariable linear regression was used to determine which maternal and delivery characteristics were associated with the Labor Agentry Scale score. Eligible characteristics included age, self-reported race and ethnicity, marital status, employment status, type of insurance, previous pregnancy loss before 20 weeks of gestation, body mass index (BMI), smoking, alcohol use, mode of delivery, labor pain (0-10 points), and a composite of perinatal death or severe neonatal complications. Significant variables ( P <.05) were retained in the final multivariable model, and adjusted mean differences (95% CIs) between groups were estimated., Results: Of 6,106 people enrolled in the trial, 6,038 experienced labor, of whom 5,750 (95.2%) completed the Labor Agentry Scale and were included in this analysis. Mean [95% CI] adjusted Labor Agentry Scale scores were significantly lower among those who identified as Asian (-6.4 [-10.5 to -2.3]) or Hispanic (-3.7 [-5.7 to -1.7]) compared with White, smoked compared with did not smoke (-2.8 [-5.5 to -0.1]), had BMIs of 35 or higher compared with less than 30 (-2.0 [-3.8 to -0.2]), were unemployed (-3.15 [-4.76 to -1.55]), did not have private health insurance (-2.61 [-4.47 to -0.76]), underwent operative vaginal (-5.1 [-7.7 to -2.6]) or cesarean (-14.4 [-16.1 to -12.6]) delivery compared with spontaneous vaginal delivery, and reported greater labor pain score of 8 or higher compared with less than 8 (-11.9 [-13.4 to -10.4]). Mean [95% CI] adjusted Labor Agentry Scale scores were significantly higher among people who were employed compared with unemployed (3.2 [1.6-4.8]) and had private compared with nonprivate insurance (2.6 [0.76-4.5])., Conclusion: In nulliparous people at low risk, unemployment, lack of private health insurance, Asian race, Hispanic ethnicity, smoking, operative delivery, and more labor pain were associated with lower perceived control during labor., Clinical Trial Registration: ClinicalTrials.gov , NCT01990612., Competing Interests: Financial Disclosure Alan T.N. Tita disclosed that money was paid to his institution from Pfizer. Geeta K. Swamy disclosed that she received payment from GlaxoSmithKline, Pfizer, and UpToDate. She has also been a consultant for Moderna. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate heavy menstrual bleeding treatment outcomes with levonorgestrel 52-mg intrauterine device (IUD) use in participants without body mass index (BMI) or parity restrictions., Methods: Investigators included participants aged 18-50 years with no pelvic or systemic pathology causing heavy menstrual bleeding at 29 U.S. centers in a prospective trial. Participants had up to three screening cycles with menstrual product collection for alkaline hematin blood-loss measurements. Investigators enrolled those with two menses with blood loss of 80 mL or more (values averaged for baseline blood loss), placed the IUD, and followed participants for up to six 28-day cycles. Participants collected any menstrual products used during cycles 3 and 6 for blood-loss measurement. We evaluated outcomes in participants with at least one follow-up assessment for the primary outcome of median absolute blood-loss change and, secondarily, treatment success , defined as the proportion with a final measured blood loss less than 80 mL and at least 50% reduction from baseline. We evaluated exploratory outcomes of differences in blood-loss changes by BMI and parity using Wilcoxon rank sum test., Results: Of 105 enrolled participants, 47 (44.8%) had obesity (BMI 30.0 or higher) and 29 (27.6%) were nulliparous. Baseline mean blood loss ranged from 73 to 520 mL (median 143 mL, interquartile range 112-196 mL). Eighty-nine (84.8%) had at least one evaluable follow-up evaluation. Participants had median (interquartile range) absolute blood-loss decreases at cycles 3 (n=86) and 6 (n=81) of 93.3% (86.1-97.7%) and 97.6% (90.4-100%), respectively. At cycle 6, participants without obesity (n=43) and with obesity (n=38) had similar median [interquartile range] decreases (97.6% [91.8-100%] and 97.5% [90.3-100%], respectively; P =.89), with comparable findings for nulliparous (n=25) and parous (n=56) participants (97.0% [91.7-99.1%] and 98.1% [89.9-100%], respectively; P =.43). Treatment success occurred in 81.8% (95% CI 74.2-89.4%) of 99 participants, excluding those with no outcomes due to lost to follow-up or consent withdrawal, and did not vary by BMI or parity. The most common adverse events leading to discontinuation were bleeding or cramping (n=6 [5.7%]) and expulsion (n=5 [4.8%])., Conclusion: This levonorgestrel 52-mg IUD reduces blood loss by more than 90% over 6 months compared with baseline for most users with heavy menstrual bleeding., Funding Source: Medicines360., Clinical Trial Registration: ClinicalTrials.gov , NCT03642210., Competing Interests: Financial Disclosure Mitchell D. Creinin has received speaking honoraria from Gedeon Richter, Mayne and Organon. He has served on the Advisory Boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck & Co., OLIC, Organon, and Searchlight. He has been a Consultant for Estetra SRL, Libbs, Mayne, and Medicines360, and his university department receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, HRA Pharma, Medicines360 (includes support for medical and safety oversight of this study), Merck & Co., and Sebela. Kurt T. Barnhart has served on the Advisory Board for Merck & Co. His university department receives contraceptive research funding from Bayer HealthCare, Medicines360, Merck & Co., and Sebela. Lori M. Gawron's university department receives contraceptive research funding from Bayer HealthCare, Cooper Surgical, Medicines360, Merck & Co., Sebela, Femasys, and Teva. David Eisenberg has served on the Advisory Board for Merck & Co. He has been a consultant for Evofem Biosciences and FemaSys. He has received honoraria from Omnia Education. His university department receives contraceptive research funding from Evofem Biosciences, Medicines360, Merck & Co., Myovant and Sebela. R. Garn Mabey has received research funding from Allergan, Medicines360, Mithra, and Sebela. Jeffrey T. Jensen has received payments for consulting from Bayer Healthcare, Evofem, Hope Medicine, Foundation Consumer Healthcare, Mayne Pharma, ViiV Healthcare, and TherapeuticsMD. OHSU has received research support from AbbVie, Bayer Healthcare, Daré, Estetra SPRL, Hope Medicine, Medicines360, Merck, Myovent, and Sebela. These companies and organizations may have a commercial or financial interest in the results of this research and technology. These potential conflicts of interest have been reviewed and managed by OHSU., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Competing Interests: Financial Disclosure Shelby M. Dickison disclosed that this article discusses off-label use of the double balloon catheter. Lauren Kus did not report any potential conflicts of interest.

Competing Interests: Financial Disclosure Nandini Raghuraman disclosed receiving payment from HCFocus. Jeannie Kelly reports money was paid to her institution from the PEW Charitable Trusts, the Barnes-Jewish Foundation St. Louis, the National Institute of Child Health and Human Development, and the Doris Duke COVID-19 Fund to Retain Clinical Scientists. The other authors did not report any potential conflicts of interest.

We performed a retrospective cohort study of all Type 1 cesarean scar pregnancies (n=18) or cervical pregnancies (n=5) at an academic tertiary center after treatment with a cervical double balloon catheter from 2018 to 2022 to evaluate outcomes and maternal morbidity. Cervical double balloon catheter treatment was associated with no cases (95% confidence interval 0-16%) of maternal hemorrhage treated with transfusion, hysterectomy, or ICU admission. Treatment was successfully performed by nine different obstetrics and gynecology specialists., Competing Interests: Financial Disclosure David L. Eisenberg receives research funding and serves as a consultant to Medicines360 and Evofem Biosciences, is a trainer for Organon's contraceptive implant, receives research funding from Merck, and is a consultant for and owns stock options in Femasys as well as participant of data safety monitoring board for ACI Clinical on behalf of Sebela Pharmaceuticals. He received research support as PI on trials (Phase 3) from Evofem Biosciences in addition to working with their Speakers Bureau. He has been a consultant for Global Learning Collaborative/Omnia Education–Authored CME content (articles, podcasts, webinars) on contraception. Jeannie Chen Kelly's institution received funding from the PEW Charitable Trusts, the Community Opioid Response and Evaluation (CORE) Project, the Barnes-Jewish Foundation St. Louis, and the Doris Duke COVID-19 Fund to Retain Clinical Scientist. David L. Eisenberg disclosed that this article discusses off-label use of using cervical ripening balloon for treatment of cervical and c-section ectopic pregnancies. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Financial Disclosure The author did not report any potential conflicts of interest.

Isolated marijuana use is frequently used as an indication for urine drug screening in labor and delivery units. We aimed to identify the results of urine drug screening in a labor and delivery unit for isolated marijuana use. This retrospective cohort study reviewed data from patients admitted for delivery at an urban academic center from January 1, 2020, to December 31, 2020. Patients undergoing urine drug screening for isolated marijuana use were more likely to be younger (median age 25 vs 29 years, P <.001), more often Black (adjusted odds ratio [aOR] 2.58, 95% CI 1.94-3.41), and more likely to have public insurance (aOR 1.54, 95% CI 1.21-1.95). A few (5/338, 1.5%) urine drug screening tests performed for isolated marijuana use were positive for substances besides marijuana. Most patients (177/197, 89.8%) with a urine drug screening test result that was positive for marijuana were reported to the state child abuse hotline. The utility of isolated marijuana use as a criterion for urine drug screening thus appears limited in benefit but rife with inequitable potential to harm., Competing Interests: Financial Disclosure Ebony Carter disclosed that money was paid to her institution from the American Diabetes Association, NIH/NIMH, and the Robert Wood Johnson Foundation. She is part of and receives payment for Carter Expert and Strategic Consulting. Jeannie Kelly disclosed that money was paid to their institution from the PEW Charitable Trusts: Community Opioid Response and Evaluation (CORE) Project ID 00033770, the NICDH, Doris Duke, and the Barnes Jewish Foundation. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To assess whether obesity is associated with increased time to pregnancy in a cohort of participants who were stopping their contraceptive method to attempt pregnancy., Methods: We performed a secondary analysis of the FACT (Fertility After Contraceptive Termination) study. This prospective analysis included 432 participants, aged 18-35 years, who discontinued contraception to become pregnant, were sexually active with a male partner, and provided pregnancy status data within the first 12 months in the study. The primary outcome, time to pregnancy, was measured beginning with discontinuation of contraception to estimated pregnancy date. We used Cox proportional hazard models to assess associations of normal (lower than 25.0), overweight (25.0-29.9), and obese (30 or higher) body mass index (BMI) and time to pregnancy while controlling for potential confounding factors., Results: After adjusting for confounders, participants with BMIs 30 or higher were noted to have prolonged time to pregnancy compared with those with BMIs lower than 25 (adjusted hazard ratio [aHR] 0.62; 95% CI 0.44-0.89). The median time to pregnancy for participants with normal BMIs was 5.3 months (95% CI 3.8-6.4) compared with 8.2 months (95% CI 6.8-10.8) for participants with obesity. Pregnancy rates at 1 year were 76.4% (95% CI 69.7-82.6%), 69.5% (95% CI 60.5-78.1%), and 59.1% (95% CI 51.0-67.4%) for participants with BMIs lower than 25, 25-29.9, and 30 or higher, respectively. Menstrual irregularity was also associated with decreased fertility (aHR 0.67; 95% CI 0.46-0.97)., Conclusion: Compared with participants with normal BMIs, we observed increased time to pregnancy for participants with obesity stopping contraception with the intention to become pregnant. Understanding the reasons for this association will be helpful to inform patients and guide clinical practice., Funding Source: The FACT Study was funded, in part, by Bayer, CooperSurgical, and the Society of Family Planning., Competing Interests: Financial Disclosure The Perelman School of Medicine Department of Obstetrics and Gynecology (Courtney A. Schreiber) has received research funding from Bayer Healthcare, Sebela, and Medicines360. Dr. Teal has served on a scientific advisory board for Bayer Healthcare and a data safety and monitoring board for a product marketed by Merck & Co. The University of Colorado Department of Obstetrics and Gynecology (Stephanie Teal) has received research funding from Bayer Healthcare, Sebela, Agile Therapeutics, Merck & Co, and Medicines360. David K. Turok serves as a consultant for Sebela Pharmaceuticals. His institution, the University of Utah Department of Obstetrics and Gynecology, receives research support from Bayer Healthcare, Cooper Surgical, Femasys, Medicines360, Merck & Co, and Sebela. Melissa Natavio has served as a consultant for Foundation Consumer Healthcare. Jeffrey F. Peipert has served on an advisory board for Bayer, CooperSurgical, and OCON and has received research support from Merck, Bayer, and CooperSurgical/Teva. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection., Methods: We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation)., Results: Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53-0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02-0.07)., Conclusion: We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making., Competing Interests: Financial Disclosure Brenna Hughes disclosed receiving funding from Merck, and she is a scientific advisor for the CMV program. She disclosed that this article includes unlabeled/investigational uses of IND, and the status of this is disclosed in the manuscript. Mara Dinsmoor received funds from law firms for expert review and Eli Lilly and Allergan for FDA-required postmarking monitoring. Robert Pass disclosed serving on the Scientific Advisory Board and receiving funding from Moderna. He has served as consultant to two firms for medical malpractice defense (no testimony and relationships are not ongoing). He has also held stock in Astra Zeneca. Rebecca Clifton disclosed that the article includes unlabeled/investigational uses of CMV hyperimmune globulin, and the status of this is disclosed in the manuscript. Frances Saccoccio disclosed that money was paid to their institution through a Derfner Research Foundation and Children's Hospital Miracle Network grants. Cynthia Gyamfi-Bannerman received funding from Medela and Hologic. Alan Tita disclosed that money was paid to his institution from Merck for Mothers and Pfizer. Kent Heyborne disclosed that the article includes unlabeled/investigational uses of IVIG for the prevention of congenital CMV infection, and the status of these is disclosed in the manuscript. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Financial Disclosure Marta Perez disclosed receiving a consulting fee from Bayer Pharmaceuticals for a Physician Speaker Series (approximately five lectures and teaching sessions about IUD use). The other authors did not report any potential conflicts of interest.

Background: Standard treatment for placental site trophoblastic tumor is hysterectomy. This may be unacceptable to women desiring fertility. Cells aberrant in placental site trophoblastic tumor display an ability to invade normal tissue while evading the immune system., Case: We present a case of a 23-year-old woman with stage I placental site trophoblastic tumor who declined hysterectomy. Tumor assay for program cell death-ligand 1 staining was performed and suggestive of an immune-responsive tumor. The patient initiated intravenous pembrolizumab 200 mg every 2 weeks, and by cycle 3 her β-hCG level fell to undetectable. She subsequently conceived and went on to have an uncomplicated term vaginal birth after cesarean. At 6 weeks postpartum, she remained without evidence of disease., Conclusion: Immunotherapy can eliminate early program cell death-ligand 1-positive placental site trophoblastic tumor with subsequent normal pregnancy., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Financial Disclosure Joshua I. Rosenbloom reports receiving funds from Anchora Medical. The other authors did not report any potential conflicts of interest.

Objective: To evaluate the length of the second stage of labor in twin deliveries and to compare the length of the second stage in twin and singleton gestations., Methods: This is a retrospective cohort study from three large hospitals in Israel. Clinical data were collected from the electronic medical record. The primary outcome was the length of the second stage (the time from documented 10-cm dilation until spontaneous vaginal delivery of the first twin). Multivariable linear regression was used to examine the association of clinical factors with the length of the second stage. The length of the second stage in twin and singleton pregnancies was compared., Results: From 2011 to June, 2020, there were 2,009 twin deliveries and 135,217 singleton deliveries. Of the twin deliveries, 655 (32.6%) of the patients were nulliparous (95th percentile length of the second stage 3 hours and 51 minutes), 1,235 (61.5%) were parous (95th percentile 1 hour 56 minutes), and 119 (5.9%) were grand multiparous (five or more prior deliveries) (95th percentile 1 hour 24 minutes). In women delivering twins, epidural use was associated with a statistically significant increase in the length of the second stage of 40 minutes in nulliparous patients and 15 minutes in parous patients. In all groups, the length of the second stage was longer in patients delivering twins compared with singletons. Second-stage length longer than the 95th percentile in twins was associated with admission to the neonatal intensive care unit and need for phototherapy., Conclusion: Second-stage labor is longer in twins than singletons and is associated with obstetric history. Normal ranges for the second stage may be useful in guiding clinical practice., Competing Interests: Financial Disclosure Abraham Tsur disclosed receiving money from Pregnantech as the medical inventor of the “Lioness” and Anthem AI for MFM precision consulting. Dr. Tsur also disclosed that money was paid to his institution from New Sight. The other authors did not report any potential conflicts of interest., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To compare risks of maternal and perinatal outcomes by completed week of gestation from 39 weeks in low-risk nulliparous patients undergoing expectant management., Methods: We conducted a secondary analysis of a multicenter randomized trial of elective induction of labor at 39 weeks of gestation compared with expectant management in low-risk nulliparous patients. Participants with nonanomalous neonates, who were randomized to and underwent expectant management and attained 39 0/7 weeks of gestation, were included. Delivery gestation was categorized by completed week: 39 0/7-39 6/7 (39 weeks), 40 0/7-40 6/7 (40 weeks), and 41 0/7-42 2/7 (41-42 weeks) (none delivered after 42 2/7). The coprimary outcomes were cesarean delivery and a perinatal composite (death, respiratory support, 5-minute Apgar score 3 or less, hypoxic ischemic encephalopathy, seizure, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support). Other outcomes included a maternal composite (blood transfusion, surgical intervention for postpartum hemorrhage, or intensive care unit admission), hypertensive disorders of pregnancy, peripartum infection, and neonatal intermediate or intensive care unit admission. For multivariable analysis, P<.0125 was considered to indicate statistical significance for the coprimary outcomes., Results: Of 2,502 participants who underwent expectant management, 964 (38.5%) delivered at 39 weeks of gestation, 1,111 (44.4%) at 40 weeks, and 427 (17.1%) at 41-42 weeks. The prevalence of medically indicated delivery was 37.9% overall and increased from 23.8% at 39 weeks of gestation to 80.3% at 41-42 weeks. The frequency of cesarean delivery (17.3%, 22.0%, 37.5%; P<.001) and the perinatal composite (5.1%, 5.9%, 8.2%; P=.03) increased with 39, 40, and 41-42 weeks of gestation, respectively, and hypertensive disorders of pregnancy decreased (16.4%, 12.1%, 10.8%, P=.001). The adjusted relative risk, 95% CI (39 weeks as referent) was significant for cesarean delivery at 41-42 weeks of gestation (1.93, 1.61-2.32) and for hypertensive disorders of pregnancy at 40 weeks (0.71, 0.58-0.88) and 41-42 weeks (0.61, 0.45-0.82). None of the other outcomes were significant., Conclusion: In expectantly managed low-risk nulliparous participants, the frequency of medically indicated induction of labor, and the risks of cesarean delivery but not the perinatal composite outcome, increased significantly from 39 to 42 weeks of gestation., Competing Interests: Financial Disclosure Robert M. Silver disclosed that he is a consultant for Gestvision. Alan T.N. Tita, Edward K. Chien and Hyagriv N. Simhan disclosed that money was paid to his institution for industry research studies for clinical trials. Hyagriv N. Simhan disclosed that he is a cofounder of Naima Health, LLC. Geeta K. Swamy disclosed receiving funding from GlaxoSmithKline and Pfizer. George Saade disclosed that he is a consultant for Medicem. The other authors did not report any potential conflicts of interest., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation., Methods: We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor., Results: Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management., Conclusion: Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their "customized" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation., Clinical Trial Registration: ClinicalTrials.gov, NCT01990612.

Objective: To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management., Methods: We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested., Results: Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05)., Conclusion: Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups., Clinical Trial Registration: ClinicalTrials.gov, NCT01990612.

Objective: To describe the prevalence of hepatitis C virus (HCV) antibody, evaluate current risk factors associated with HCV antibody positivity, and identify novel composite risk factors for identification of groups most likely to demonstrate HCV antibody seropositivity in an obstetric population from 2012 to 2015., Methods: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network initiated an observational study of mother-to-child transmission of HCV in 2012 that included offering HCV antibody screening to their entire obstetric population. Women presenting for prenatal care before 23 weeks of gestation without a known multifetal gestation were eligible. For each woman who was HCV antibody-positive, two women at similar gestational age who were HCV antibody-negative were identified and included for comparison. Risk factors were evaluated by patient interview and chart review. Women in the case group were identified to have a signal-to-cutoff value of at least 5 on the Abbott ARCHITECT platform. RNA status was evaluated for women in the case group., Results: Of 106,842 women screened for the HCV antibody, 254 had positive results. The HCV antibody seroprevalence rate was 2.4 cases per 1,000 women (95% CI 2.1-2.7). One hundred thirty-one women in the case group and 251 women in the control group were included in the case-control analysis. Factors associated with HCV antibody positivity included injection drug use (adjusted odds ratio [aOR] 22.9, 95% CI 8.2-64.0), blood transfusion (aOR 3.7, 95% CI 1.3-10.4), having a partner with HCV (aOR 6.3, 95% CI 1.8-22.6), more than three lifetime sexual partners (aOR 5.3, 95% CI 1.4-19.8), and smoking (aOR 2.4, 95% CI 1.2-4.6). A composite of any of these potential risk factors provided the highest sensitivity for detecting HCV antibody (75/82 cases, 91%)., Conclusion: In this cohort, the seroprevalence of HCV antibody was low, and the current risk factors for HCV screening were not identified. These findings may be useful in defining new strategies for identifying mothers with the HCV antibody and the neonates susceptible to maternal transmission of HCV., Clinical Trial Registration: ClinicalTrials.gov, NCT01959321.

Over the past 40 years, American medicine has become corporatized. Medical care has become permeated by a business philosophy whose primary concern is increasing shareholder value rather than providing optimal care for patients. Patient-physician relationships have eroded as the health care system has turned its attention toward electronic medical records (rather than face-to-face interactions with patients), toward quantifiable ("billable") metrics, and toward calculating the relative value units delivered by various health care "providers." An emphasis on clinical efficiency has diminished the depth of patient-physician contacts and has tended to promote quick, superficial interactions. Patients in pain are often overmedicated rather than listened to and understood. Suffering (which is at bottom a problem about the meaning of illness) has lost its place as a major medical concern. It is often easier to write a prescription for a powerful narcotic than to probe the details of a patient's life. This unfortunate tendency to seek quick, pill-based solutions to pain has been reinforced by the pharmaceutical industry, which has promoted this simple but profitable approach through the aggressive marketing of oxycodone and related medications. Both patients and physicians have lost out in the process. We need to reconstruct a health care system that gives pain its due but places that pain in the larger context of a patient's suffering. This can only be done by restoring clinicians to their preeminent place in medicine. We must strive to be healers, not simply providers.

Objective: To estimate whether stillbirth at 23 weeks of gestation or more is associated with increased risk of severe maternal morbidity compared with live birth, when stratified by maternal comorbidities., Methods: This retrospective cohort study used International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis and procedure codes within the Healthcare Cost and Utilization Project's Florida State Inpatient Database. The first delivery of female Florida residents aged 13-54 years old from 2005 to 2014 was included. The exposure was an ICD-9-CM code of stillbirth at 23 weeks of gestation or more; the control was an ICD-9-CM code of singleton live birth. Deliveries were stratified by the presence of 1 or more conditions within a well-validated maternal morbidity composite using ICD-9-CM codes during delivery hospitalization. The primary outcome was an ICD-9-CM diagnosis or procedure code during delivery hospitalization of any indices within the Centers for Disease Control and Prevention's severe maternal morbidity composite. Multivariable analyses adjusted for maternal sociodemographic factors and delivery mode to compare outcomes after stillbirth with live-birth delivery., Results: Nine thousand five hundred twenty-three women who delivered stillborn fetuses and 1,353,044 with liveborn neonates were included. Among 6,590 stillbirths and 935,913 live births without maternal comorbidities, severe maternal morbidity was significantly more common during stillbirth delivery (n=345 [5.2%]), corresponding to a seven-fold increased risk compared with live birth (n=8,318 [0.9]; adjusted odds ratio [aOR] 7.05 [95% CI 6.27-7.93]). Among 2,933 stillbirths and 417,131 live births with maternal comorbidities, severe maternal morbidity was significantly more common during stillbirth delivery (n=390 [13.3%]): the risk was more than six-fold higher comparatively (n=11,122 [2.7%]; aOR 6.21 [95% CI 5.54-6.96]). Most maternal comorbidities were individually associated with higher risk of severe maternal morbidity during stillbirth compared with live-birth delivery., Conclusion: Though severe maternal morbidity is overall uncommon, delivering a stillborn fetus 23 weeks of gestation or greater is associated with increased likelihood of severe maternal morbidity, particularly among women with comorbidities, suggesting health care providers must be vigilant about severe maternal morbidity during stillbirth delivery.

Objective: To perform a systematic review of the literature on the effect of simulation training of operative vaginal delivery on learner technique and knowledge, operator comfort, and patient-centered outcomes., Data Sources: MEDLINE, EMBASE, CINAHL, Scopus, Web of Science, ERIC, The Cochrane Library, and ClinicalTrials.gov were searched from inception through April 2017. The search criteria used MeSH terms ("simulation training," "high fidelity simulation training," "teaching," "obstetrical extraction," "obstetrical forceps," "vaginal delivery," "clinical competence," and "internship and residency")., Methods of Study Selection: A total of 30,813 articles were reviewed for inclusion. Studies detailing operative vaginal delivery simulation using forceps or vacuums and reporting health care provider or patient outcomes were eligible., Tabulation, Integration, and Results: All studies were independently reviewed by two investigators for inclusion. Only eight articles assessed the effect of simulation on trainee skill and comfort or patient outcomes and were included. Four were pretest-posttest studies, two were cross-sectional studies, one was a case-control study, and one was a cohort study. No randomized trials were identified. Simulation was associated with improved forceps placement accuracy and generated force during extraction, as well as increased operator knowledge and comfort with operative vaginal delivery. Additionally, simulation had no association with forceps failure rates, but there was an association with decreased rates of maternal lacerations and neonatal injury. The quality of the included studies was assessed with the Medical Education Research Study Quality Instrument, with a median score of 9.75 (range 9.0-13.5), indicating low-to-moderate quality., Conclusion: The available evidence suggests that improved technique, comfort, knowledge, and patient outcomes are associated with operative vaginal delivery simulation, but additional studies are required to further characterize such benefits for both forceps and vacuum., Systematic Review Registration: PROSPERO, CRD42018087343.

Objective: To estimate whether nitrofurantoin prophylaxis decreases the incidence of culture-documented urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery., Methods: This double-blind, placebo-controlled, randomized trial was conducted at five academic institutions. Women with urinary retention after surgery for prolapse or incontinence were randomized to oral nitrofurantoin 100 mg daily during indwelling or clean intermittent self-catheterization. The primary outcome was the incidence of symptomatic urinary tract infection within 6 weeks of surgery, confirmed by culture demonstrating more than 1,000 colony forming units per milliliter of uropathogenic bacteria. Secondary outcomes were adverse symptoms possibly attributable to nitrofurantoin and bacterial resistance to nitrofurantoin. A sample size of 154 would detect a decrease in urinary tract infection incidence from 33% to 13%, with 80% power, two-sided alpha of 0.05, and allow 10% dropout., Results: Of 154 participants randomized from September 2016 to May 2018, 151 were eligible for analysis: 75 received nitrofurantoin, and 76 received placebo. Demographics were similar between groups. The indication for surgery was prolapse (46%), incontinence (20%), or a combination (34%). Participants were discharged with an indwelling catheter (58%) or performing self-catheterization (42%). Median duration of catheter use was 4 days (interquartile range 3-7). Thirteen women in the nitrofurantoin group and 13 women in the placebo group experienced urinary tract infection (17.3% vs 17.1%, P=.97, relative risk [RR] [95% CI] 1.01 [0.50-2.04]). Adverse symptoms possibly attributable to nitrofurantoin were common in both groups (68% vs 61%, P=.34, RR [95% CI] 1.12 [0.88-1.43]). Resistance to nitrofurantoin was identified in seven urine cultures, four among nitrofurantoin and three among placebo recipients. In total, 52 urine cultures were obtained to evaluate symptoms of urinary tract infection, and only 27 of 52 grew at least 1,000 cfu/mL of uropathogenic bacteria., Conclusion: Daily nitrofurantoin did not reduce the incidence of culture-proven urinary tract infection among women with catheter-managed urinary retention after pelvic reconstructive surgery. Culture confirmed urinary tract infection in only half of symptomatic episodes., Clinical Trial Registration: ClinicalTrials.gov, NCT02727322.

Objective: To estimate whether severe maternal morbidity is associated with increased risk of psychiatric illness in the year after delivery hospital discharge., Methods: This retrospective cohort study used International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes within Florida's Healthcare Cost and Utilization Project's databases. The first liveborn singleton delivery from 2005 to 2015 was included; women with ICD-9-CM codes for psychiatric illness or substance use disorder during pregnancy were excluded. The exposure was ICD-9-CM codes during delivery hospitalization of severe maternal morbidity, as per the Centers for Disease Control and Prevention. The primary outcome was ICD-9-CM codes in emergency department encounter or inpatient admission within 1 year of hospital discharge of composite psychiatric morbidity (suicide attempt, depression, anxiety, posttraumatic stress disorder, psychosis, acute stress reaction, or adjustment disorder). The secondary outcome was a composite of ICD-9-CM codes for substance use disorder. We compared women with severe maternal morbidity with those without severe maternal morbidity using multivariable logistic regression adjusting for sociodemographic factors and medical comorbidities. Cox proportional hazard models identified the highest risk period after hospital discharge for the primary outcome., Results: A total of 15,510 women with severe maternal morbidity and 1,178,458 without severe maternal morbidity were included. Within 1 year of hospital discharge, 2.9% (n=452) of women with severe maternal morbidity had the primary outcome compared with 1.6% (n=19,279) of women without severe maternal morbidity, resulting in an adjusted odds ratio (aOR) 1.74 (95% CI 1.58-1.91). The highest risk interval was within 4 months of discharge (adjusted hazard ratio [adjusted HR] 2.53 [95% CI 2.05-3.12]). Most severe maternal morbidity conditions were associated with higher risk of postpartum psychiatric illness. Women with severe maternal morbidity had nearly twofold higher risk of postpartum substance use disorder (170 [1.1%] vs 6,861 [0.6%]; aOR 1.91 [95% CI 1.64-2.23])., Conclusion: Though absolute numbers were modest, severe maternal morbidity was associated with increased risk of severe postpartum psychiatric morbidity and substance use disorder. The highest period of risk extended to 4 months after hospital discharge.

Background: Dermatomyositis is an inflammatory myopathy that has an increased risk of malignancy, warranting aggressive health maintenance screenings. Dermatomyositis can rarely present with vulvovaginitis, thus clinical suspicion is important in early diagnosis., Case: We present the case of a 31-year-old woman with a 10-year history of vulvovaginitis as her presenting symptom of dermatomyositis. On further investigation, she had a history of joint pain, muscle pain, fatigue, and leukopenia. On examination, she was found to have a rash and mucopurulent vulvovaginitis. Biopsies from the chest, axilla, and vulva were compatible with dermatomyositis. Evaluation for malignancy was negative, and her symptoms resolved with treatment of the dermatomyositis., Conclusion: Dermatomyositis is an inflammatory disease that can be associated with malignancy. This particular patient presented with vulvovaginitis. This case is important because the diagnosis was delayed. Early recognition is important to evaluate for malignancy.

Objective: To assess the menstrual hygiene needs of low-income women in St. Louis, Missouri., Methods: Using an exploratory, cross-sectional design, women 18 years of age and older were recruited from a purposive sample of 10 not-for-profit community organizations that serve low-income women in St. Louis. From July 2017 to March 2018, 183 interviewer-administered surveys and three focus group discussions were conducted. Surveys and focus groups identified where and how women access menstrual hygiene products and what they do when they cannot afford to buy them. Using a snowball sampling strategy, 18 community organizations were also surveyed electronically to assess what services and supplies they provide for menstrual hygiene., Results: All women invited to participate in the interviews and the focus groups agreed to do so. Nearly two thirds (64%) of women were unable to afford needed menstrual hygiene supplies during the previous year. Approximately one fifth of women (21%) experienced this monthly. Many women make do with cloth, rags, tissues, or toilet paper; some even use children's diapers or paper towels taken from public bathrooms. Nearly half of women (46%) could not afford to buy both food and menstrual hygiene products during the past year. There was no difference in menstrual hygiene needs by age. Two thirds of organizations indicated that menstrual hygiene was a need of their clients. Thirteen provide menstrual hygiene supplies to their clients; two provide menstrual hygiene education., Conclusion: Menstrual hygiene supplies are a basic necessity that many low-income women lack. We document the extent to which low-income women in a major metropolitan area in the United States are unable to afford these basic necessities and what they do to cope. Women's health care providers should advocate for improved access to menstrual hygiene supplies for low-income females across the United States.

Objective: To analyze clinical prognostic factors for survival after recurrence of high-grade, advanced-stage ovarian-peritoneal-tubal carcinoma and to develop a nomogram to predict individual survival after recurrence., Methods: We retrospectively analyzed patients treated in multicenter Gynecologic Oncology Group protocols for stage III and IV ovarian-peritoneal-tubal carcinoma who underwent primary debulking surgery, received chemotherapy with paclitaxel and a platinum compound, and subsequently developed recurrence. Prognostic factors affecting survival were identified and used to develop a nomogram, which was both internally and externally validated., Results: There were 4,739 patients included in this analysis, of whom, 84% had stage III and 16% had stage IV ovarian carcinoma. At a median follow-up of 88.8 months (95% CI 86.2-92.0 months), the vast majority of patients (89.4%) had died. The median survival after recurrence was 21.4 months (95% CI 20.5-21.9 months). Time to recurrence after initial chemotherapy, clear cell or mucinous histology, performance status, stage IV disease, and age were significant variables used to develop a nomogram for survival after recurrence, which had a concordance index of 0.67. The time to recurrence alone accounted for 85% of the prognostic information. Similar results were found for patients who underwent second look laparotomy and had a complete pathologic response or received intraperitoneal chemotherapy., Conclusion: For individuals with advanced-stage ovarian carcinoma who recur after standard first-line therapy, estimated survivals after recurrence are closely related to the time to recurrence after chemotherapy and prognostic variables can be used to predict subsequent survival., Clinical Trial Registration: ClinialTrials.gov, NCT00002568, NCT00837993, NCT00002717, NCT01074398, and NCT00011986.

Objective: To compare the independent risk of neonatal morbidity between the offspring of obese and nonobese women without hypertension or diabetes., Methods: This is a secondary analysis of a prospective single-center cohort study of singleton deliveries at or beyond 37 weeks of gestation from 2010 to 2014. Women with diabetes (pregestational or gestational) and hypertensive disorders were excluded. The primary outcomes were 1) a composite neonatal morbidity including death, mechanical ventilation, respiratory distress, meconium aspiration, suspected sepsis, confirmed sepsis, hypoxic-ischemic encephalopathy, therapeutic hypothermia, or seizures; and 2) a composite of neonatal neurologic morbidity including hypoxic-ischemic encephalopathy, therapeutic hypothermia, or seizures. The primary outcomes were compared between the offspring of obese (body mass index 30 or greater) and nonobese women. Adjusted odds ratios (ORs) were estimated using multivariable logistic regression., Results: Of 6,458 women without diabetes or hypertensive disorders, 3,311 (51%) were obese. After adjusting for race, neonates of obese patients were at significantly increased risk for the composite neonatal morbidity (9.2% vs 7.2%, adjusted OR 1.39, 95% CI 1.15-1.67) and neurologic neonatal morbidity (0.7% vs 0.3%, adjusted OR 2.84, 95% CI 1.22-6.65). Specifically, neonates of obese patients were more likely to have hypoxic-ischemic encephalopathy (0.5% vs 0.2%, adjusted OR 2.80, 95% CI 1.02-7.68), hypothermia treatment (0.6% vs 0.2%, adjusted OR 2.92 95% CI 1.17-7.30), and suspected sepsis (7.6% vs 5.8%, adjusted OR 1.45, 95% CI 1.18-1.79)., Conclusion: In patients who labor, maternal obesity is an independent risk factor for significant neonatal morbidity, even in the absence of hypertensive disorders or diabetes.

Objective: To investigate the cost-effectiveness of adding azithromycin to standard cephalosporin regimens of cesarean delivery prophylaxis by considering the maternal outcomes in the current and potential subsequent pregnancies., Methods: A cost-effectiveness model was created using TreeAge to compare the outcomes of using azithromycin-cephalosporin with cephalosporin alone in a theoretical cohort of 700,000 women, the approximate number of nonelective cesarean deliveries annually in the United States that occur during labor or after membrane rupture. Outcomes examined included endometritis, wound infection, sepsis, venous thromboembolism, and maternal death in the current pregnancy and uterine rupture, cesarean hysterectomy, and maternal death in subsequent pregnancies, including cost and quality-adjusted life-years for both pregnancies. Probabilities, utilities, and costs were derived from the literature, and a cost-effectiveness threshold was set at $100,000 per quality-adjusted life-year. Sensitivity analyses were used to determine the robustness of our results., Results: Compared with cephalosporin alone for prophylaxis, our model showed 16,100 fewer cases of endometritis, 17 fewer cases of sepsis, eight fewer cases of venous thromboembolism, and one fewer maternal death with azithromycin-cephalosporin. Additionally, this strategy prevented 36 uterine ruptures and four cesarean hysterectomies in the subsequent pregnancy. Overall, the addition of azithromycin led to both lower costs and higher quality-adjusted life-years when compared with standard cephalosporin prophylaxis. In sensitivity analysis, we found that as long as the cost of azithromycin remained below $930 (baseline cost $27), it was cost-effective., Conclusion: For women who undergo cesarean delivery in labor or after membrane rupture, compared with cephalosporin alone, the addition of azithromycin to cesarean delivery infection prophylaxis is less costly and leads to better maternal outcomes in the index delivery and subsequent deliveries. These findings support the use of prophylactic azithromycin at the time of cesarean delivery.

Objective: To estimate the risk of adverse perinatal outcomes among women with isolated fetal growth restriction from 17 to 22 weeks of gestation., Methods: This was a retrospective cohort study of all singleton, nonanomalous pregnancies undergoing ultrasonography to assess fetal anatomy between 17 and 22 weeks of gestation at a single center from 2010 to 2014. After excluding patients with fetal structural malformations, chromosomal abnormalities, or identified infectious etiologies, we compared perinatal outcomes between pregnancies with and without fetal growth restriction, defined as estimated fetal weight less than the 10th percentile for gestational age. Our primary outcome was small for gestational age (SGA) at birth, defined as birth weight less than the 10th percentile. Secondary outcomes included preterm delivery at less than 37 and less than 28 weeks of gestation, preeclampsia, abruption, stillbirth, neonatal death, neonatal intensive care unit admission, intraventricular hemorrhage, need for respiratory support, and necrotizing enterocolitis., Results: Of 12,783 eligible patients, 355 (2.8%) had early second-trimester fetal growth restriction. Risk factors for growth restriction were African American race and tobacco use. Early second-trimester growth restriction was associated with a more than fivefold increase in risk of SGA at birth (36.9% compared with 9.1%, adjusted odds ratio [OR] 5.5, 95% CI 4.3-7.0), stillbirth (2.5% compared with 0.4%, OR 6.2, 95% CI 2.7-12.8), and neonatal death (1.4% compared with 0.3%, OR 5.2, 95% CI 1.6-13.5). Rates of indicated preterm birth at less than 37 weeks of gestation (7.3% compared with 3.3%, OR 2.3, 95% CI 1.5-3.5) and less than 28 weeks of gestation (2.5% compared with 0.2%, OR 10.8, 95% CI 4.5-23.4), neonatal need for respiratory support (16.9% compared with 7.8%, adjusted OR 1.6, 95% CI 1.1-2.2), and necrotizing enterocolitis (1.4% compared with 0.2%, OR 7.7, 95% CI 2.3-20.9) were also significantly higher for those with growth restriction. Rates of preeclampsia, abruption, and other neonatal outcomes were not significantly different., Conclusion: Although fetal growth restriction in the early second trimester occurred in less than 3% of our cohort and most of those with isolated growth restriction did not have adverse outcomes, it is a strong risk factor for SGA, stillbirth, neonatal death, and indicated preterm birth.

Objective: To estimate whether marijuana use in pregnancy increases risks for adverse neonatal outcomes and clarify if any increased risk is attributable to marijuana use itself or to confounding factors such as tobacco use., Data Sources: Two authors performed a search of the data through August 2015 utilizing PubMed, Embase, Scopus, Cochrane reviews, ClinicalTrials.gov, and Cumulative Index to Nursing and Allied Health., Methods of Study Selection: We looked at observational studies that compared rates of prespecified adverse neonatal outcomes in women who used marijuana during pregnancy with women who did not., Tabulation, Integration, and Results: Two authors independently extracted data from the selected studies. Primary outcomes were low birth weight (less than 2,500 g) and preterm delivery at less than 37 weeks of gestation. Secondary outcomes were birth weight, gestational age at delivery, small for gestational age, level II or greater nursery admission, stillbirth, spontaneous abortion, low Apgar score, placental abruption, and perinatal death. DerSimonian-Laird random-effects models were used. We assessed heterogeneity using the Q test and I statistic. Stratified analyses were performed for the primary outcomes and pooled adjusted estimates were calculated. We included 31 studies that assessed the effects of maternal marijuana use on adverse neonatal outcomes. Based on pooled unadjusted data, marijuana use during pregnancy was associated with an increased risk of low birth weight (15.4% compared with 10.4%, pooled relative risk [RR] 1.43, 95% confidence interval [CI] 1.27-1.62) and preterm delivery (15.3% compared with 9.6%, pooled RR 1.32, 95% CI 1.14-1.54). However, pooled data adjusted for tobacco use and other confounding factors showed no statistically significant increased risk for low birth weight (pooled RR 1.16, 95% CI 0.98-1.37) or preterm delivery (pooled RR 1.08, 95% CI 0.82-1.43)., Conclusion: Maternal marijuana use during pregnancy is not an independent risk factor for adverse neonatal outcomes after adjusting for confounding factors. Thus, the association between maternal marijuana use and adverse outcomes appears attributable to concomitant tobacco use and other confounding factors.

Objective: To compare perioperative outcomes of uncontained and contained power morcellation in total laparoscopic hysterectomy., Methods: Women who underwent total laparoscopic hysterectomy that required utilization of power morcellation between July 2012 and January 2015 in the Division of Minimally Invasive Gynecology at an academic tertiary care center were included. In February 2014, the division began performing all power morcellation contained within a large insufflated bag in an attempt to reduce dissemination of benign and malignant uterine tissue. Data were collected from a prospective database and analyzed as a retrospective cohort. The primary outcome was operative time. Secondary outcomes included estimated blood loss, length of stay, pathology, uterine weight, and complications, including blood transfusion, conversion to open, intraoperative organ injury, pelvic infection, readmission, or reoperation., Results: A total of 152 patients were identified: 101 uncontained morcellations and 51 contained morcellations. The baseline demographic characteristics between the two groups were similar. Operative time was longer in the contained morcellation group (184 compared with 164 minutes, P=.01). There were no cases of visible bag disruption or dissemination of uterine tissue in the contained morcellation group., Conclusion: Contained power morcellation at the time of total laparoscopic hysterectomy is associated with a 20-minute increase in operative time when compared with uncontained morcellation., Level of Evidence: II.

Objective: To evaluate the perceptions of fellowship program directors of incoming clinical fellows for subspecialty training., Methods: A validated survey by the American College of Surgeons was modified and distributed to all fellowship program directors in four subspecialties within obstetrics and gynecology: female pelvic medicine and reconstructive surgery, gynecologic oncology, maternal-fetal medicine, and reproductive endocrinology-infertility. The 59-item survey explored five domains concerning preparedness for fellowship: professionalism, independent practice, psychomotor ability, clinical evaluation, and academic scholarship. A Likert scale with five responses was used and tailored to each subspecialty. Standard statistical methods were used to compare responses between subspecialties and to analyze data within each subspecialty individually., Results: One hundred thirty directors completed the survey, for a response rate of 60%. In the domain of professionalism, more than 88% of participants stated that incoming fellows had appropriate interactions with faculty and staff. Scores in this domain were lower for gynecologic oncology respondents (P=.046). Responses concerning independent practice of surgical procedures (hysterectomy, pelvic reconstruction, and minimally invasive) were overwhelmingly negative. Only 20% of first-year fellows were able to independently perform a vaginal hysterectomy, 46% an abdominal hysterectomy, and 34% basic hysteroscopic procedures. Appropriate postoperative care (63%) and management of the critically ill patient (71%) were rated adequate for all subspecialties., Conclusion: Graduating residents may be underprepared for advanced subspecialty training, necessitating an evaluation of the current structure of resident and fellow curriculum., Level of Evidence: III.

Objective: To identify patterns of contraceptive use and pregnancy in an academic adult congenital cardiology practice., Methods: In this cross-sectional study, from October 2013 through March 2014, 100 women with congenital heart disease aged 18-45 years were recruited from an academic congenital heart disease clinic and administered a survey regarding pregnancy history, contraception use, and understanding of pregnancy-related and contraceptive-related risk. The primary outcome was current use of long-acting reversible contraception, including intrauterine devices or subdermal implants., Results: Of 83 sexually active women, 63 (75.9%, 95% confidence interval [CI] 65.3-85.1) reported currently using any contraceptive method, including 30 of 83 (36.1%, 95% CI 25.9-47.4) using tier I methods (typical-use failure rates of less than 1% per year) and 20 of 83 (24.1%, 95% CI 15.4-34.7) using tier II methods (typical-use failure rates of 6-12% per year). Nine of 83 (10.8%, 95% CI 5.1-19.6) reported currently using long-acting reversible contraception. Sixty-four of 141 total pregnancies (45.4%, 95% CI 31.9-58.9) were self-reported by participants as "unexpected" rather than "planned." Only one (1.6%, 95% CI 0-4.6) of the 64 unintended pregnancies occurred when the woman was using a tier I method of contraception at the time of conception., Conclusion: Most women with congenital heart disease of childbearing age are sexually active. The high incidence of unintended pregnancy in this group may be related to underuse of highly effective methods of contraception. Specific counseling on tier I methods may reduce unintended pregnancies in women with congenital heart disease., Level of Evidence: III.

Objective: To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration (FDA)-approved duration of 3 and 5 years, respectively., Methods: Women willing to continue using their implant or 52-mg levonorgestrel IUD beyond the FDA-approved duration were followed prospectively for contraceptive effectiveness. Unintended pregnancy rate per 100 women-years was calculated. Implant users are offered periodic venipuncture for analysis of serum etonogestrel levels. The Kruskal-Wallis test was used to compare the etonogestrel levels across body mass index (BMI) groups., Results: Implant users (n=237) have contributed 229.4 women-years of follow-up, with 123 using the etonogestrel implant for 4 years and 34 using it for 5 years. Zero pregnancies have been documented, for a failure rate of 0 (one-sided 97.5% confidence interval [CI] 0-1.61) per 100 women-years. Among 263 levonorgestrel IUD users, 197.7 women-years of follow-up have been completed. One pregnancy was confirmed, for a failure rate of 0.51 (95% CI 0.01-2.82) per 100 women-years. Among implant users with serum etonogestrel results, the median and range of etonogestrel level at 3 years of use was 188.8 pg/mL (range 63.8-802.6 pg/mL) and 177.0 pg/mL (67.9-470.5 pg/mL) at 4 years of use. Etonogestrel levels did not differ by BMI at either time point (3 years: P=.79; 4 years: P=.47)., Conclusion: Preliminary findings indicate the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for an additional year beyond the FDA-approved 3 and 5 years. Serum etonogestrel levels indicate the implant contains adequate hormone for ovulation suppression at the end of both 3 and 4 years of use., Level of Evidence: II.

Objective: To investigate whether age 14 to 19 years and nulliparity are associated with expulsion of levonorgestrel and copper intrauterine devices (IUDs)., Methods: This was a planned secondary analysis of the Contraceptive CHOICE Project. We used Kaplan-Meier survival analysis to estimate expulsion rates for the first levonorgestrel or copper IUD received during study participation. Cox proportional hazards regression models were used to investigate baseline characteristics associated with expulsion., Results: A total of 5,403 females were included; 4,219 (78%) used the levonorgestrel IUD and 1,184 (22%) used the copper IUD. There were 432 initial expulsions reported. The 36-month cumulative expulsion rate was 10.2 per 100 IUD users and did not vary by IUD type (levonorgestrel IUD 10.1 compared with copper IUD 10.7, P=.99). In the bivariate analysis, multiple characteristics including age, nulliparity, immediate postabortion insertion, and heavy menses were associated with expulsion. The cumulative rate of expulsion was lower in nulliparous women compared with parous women (8.4 compared with 11.4; P<.001) and higher in females aged 14 to 19 compared with older women (18.8 compared with 9.3; P<.001). After adjusting for confounders and stratifying by IUD type, the hazard ratio of expulsion for females aged 14 to 19 years was 2.26 (95% confidence interval [CI] 1.68-3.06) for the levonorgestrel IUD and 3.06 (95% CI 1.75-5.33) for the copper IUD. Compared to parous levonorgestrel IUD users, expulsion was lower for nulliparous levonorgestrel IUD users (adjusted hazard ratio 0.59, 95% CI 0.44-0.78)., Conclusion: IUD expulsions were not increased in nulliparous females. More expulsions were observed in females aged 14 to 19 compared with older women regardless of parity or IUD type., Level of Evidence: : II.

Objective: To estimate the risk of stillbirth among pregnancies complicated by a major isolated congenital anomaly detected by antenatal ultrasonography and the influence of incidental growth restriction., Methods: A retrospective cohort study of all consecutive singleton pregnancies undergoing routine anatomic survey between 1990 and 2009 was performed. Stillbirth rates among fetuses with an ultrasound-detected isolated major congenital anomaly were compared with fetuses without major anomalies. Stillbirth rates were calculated per 1,000 ongoing pregnancies. Exclusion criteria included delivery before 24 weeks of gestation, multiple fetal anomalies, minor anomalies, and chromosomal abnormalities. Analyses were stratified by gestational age at delivery (before 32 weeks compared with 32 weeks of gestation or after) and birth weight less than the 10th percentile. We adjusted for confounders using logistic regression., Results: Among 65,308 singleton pregnancies delivered at 24 weeks of gestation or after, 873 pregnancies with an isolated major congenital anomaly (1.3%) were identified. The overall stillbirth rate among fetuses with a major anomaly was 55 per 1,000 compared with 4 per 1,000 in nonanomalous fetuses (adjusted odds ratio [OR] 15.17, 95% confidence interval [CI] 11.03-20.86). Stillbirth risk in anomalous fetuses was similar before 32 weeks of gestation (26/1,000) and 32 weeks of gestation or after (31/1,000). Among growth-restricted fetuses, the stillbirth rate increased among anomalous (127/1,000) and nonanomalous fetuses (18/1,000), and congenital anomalies remained associated with higher rates of stillbirth (adjusted OR 8.20, 95% CI 5.27-12.74)., Conclusion: The stillbirth rate is increased in anomalous fetuses regardless of incidental growth restriction. These risks can assist practitioners in designing care plans for anomalous fetuses who have elevated and competing risks of stillbirth and neonatal death., Level of Evidence: II.

Objective: To report the incidence of neonatal brachial plexus palsy with and without ipsilateral clavicle fracture in a population of newborns and to compare the prognosis between these subgroups., Methods: This was a retrospective review of 3,739 clavicle fractures and 1,291 brachial plexus palsies in neonates over a 24-year period from a geographically defined health care system with reference to county-wide population data., Results: A referral clinic for children with brachial plexus palsies evaluated 1,383 neonates, of whom 320 also had ipsilateral clavicular fracture. As a result of referral patterns within the region, it is likely that this represents nearly all infants from the area with persistent brachial plexus injury after 2 months of age. Among the children evaluated without concomitant clavicular fracture, 72% resolved spontaneously (154/214); among those with concomitant clavicular fracture, 74% healed spontaneously (55/74). Limiting the analysis to neonates delivered at Parkland Memorial Hospital and assuming that those neonates with a discharge diagnosis of brachial plexus injury with or without clavicular fracture who did not present to the referral brachial plexus injury clinic had complete resolution, 94.4% without clavicular fracture resolved and 98.1% with clavicular fracture resolved (P=.005)., Conclusions: The risk of persistent neurologic deficit from a birth-related brachial plexus palsy is lower than what has been reported, and the presence of a clavicle fracture may improve the likelihood of recovery., Level of Evidence: III.

Objective: To estimate whether providing no-cost contraception is associated with the number of sexual partners and frequency of intercourse over time., Methods: This was an analysis of the Contraceptive CHOICE Project, a prospective cohort study of 9,256 adolescents and women at risk for unintended pregnancy. Participants were provided reversible contraception of their choice at no cost and were followed-up with telephone interviews at 6 and 12 months. We examined the number of male sexual partners and coital frequency reported during the previous 30 days at baseline compared with 6-month and 12-month time points., Results: From our total cohort, 7,751 (84%) women and adolescents completed both 6-month and 12-month surveys and were included in this analysis. We observed a statistically significant decrease in the fraction of women and adolescents who reported more than one sexual partner during the past 30 days from baseline to 12 months (5.2% to 3.3%; P<.01). Most participants (70-71%) reported no change in their number of sexual partners at 6 and 12 months, whereas 13% reported a decrease and 16% reported an increase (P<.01). More than 80% of participants who reported an increase in the number of partners experienced an increase from zero to one partner. Frequency of intercourse increased during the past 30 days from baseline (median, 4) to 6 and 12 months (median, 6; P<.01). However, greater coital frequency did not result in greater sexually transmitted infection incidence at 12 months., Conclusion: We found little evidence to support concerns of increased sexual risk-taking behavior subsequent to greater access to no-cost contraception.

Objective: To assess whether loop electrosurgical excision procedure (LEEP) increases the risk for preterm birth before 37 weeks of gestation and clarify whether the increased risk for preterm birth is attributable to the procedure itself or to risk factors associated with cervical dysplasia., Data Sources: Two authors performed a search of the relevant data through February 2013 using PubMed, Embase, Scopus, CENTRAL, and ClinicalTrials.gov., Methods of Study Selection: We included observational studies that compared rates of preterm birth in women with prior LEEP with women with no history of cervical excision. Nineteen of 559 identified studies met selection criteria., Tabulation, Integration, and Results: We compared women with a history of LEEP with two unexposed groups without a history of cervical excision: 1) women with an unknown or no history of cervical dysplasia; and 2) women with a history of cervical dysplasia but no cervical excision. The primary outcome was preterm birth before 37 weeks of gestation. Secondary outcomes were preterm birth before 34 weeks of gestation, spontaneous preterm birth, preterm premature rupture of membranes, and perinatal mortality. DerSimonian-Laird random effects models were used. We assessed heterogeneity between studies using the Q and I tests. Stratified analyses and metaregression were performed to assess confounding. Nineteen studies were included with a total of 6,589 patients with a history of LEEP and 1,415,015 without. Overall, LEEP was associated with an increased risk of preterm birth before 37 weeks of gestation (pooled relative risk 1.61, 95% confidence interval [CI] 1.35-1.92). However, no increased risk was found when women with a history of LEEP were compared with women with a history cervical dysplasia but no cervical excision (pooled relative risk 1.08, 95% CI 0.88-1.33)., Conclusion: Women with a history of LEEP have similar risk of preterm birth when compared with women with prior dysplasia but no cervical excision. Common risk factors for both preterm birth and dysplasia likely explain findings of association between LEEP and preterm birth, but LEEP itself may not be an independent risk factor for preterm birth.