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Background: Pregnancy in women with sickle-cell disease (SCD) is associated with increased adverse outcomes. Findings on the association between SCD and adverse pregnancy outcomes are conflicting, and the results do not address whether these associations are similar in both low- and high-income countries.Objectives: We conducted a systematic review and meta-analysis to evaluate pregnancy outcomes associated with SCD.Search Strategy: The MEDLINE database was searched using medical subject headings (MeSH) and keywords for articles on pregnancy outcomes in women with SCD.Selection Criteria: We used full research articles published in English that compared women with SCD with women who did not have SCD, as controls.Data Collection and Analysis: Data were abstracted and analysed using comprehensive Meta-analysis 2.2. The primary outcomes were intrauterine growth restriction and perinatal mortality. Secondary outcomes were rates of caesarean sections, pre-eclampsia, eclampsia, postpartum haemorrhage, maternal mortality, prematurity, and low birthweight. Random-effects models were used to calculate pooled odds ratios (ORs) with 95% confidence intervals (95% CIs).Main Results: Sixteen studies met all of the selection criteria and were included in the analysis. SCD was associated with intrauterine growth restriction (pooled OR 2.79, 95% CI 1.85-4.21), perinatal mortality (pooled OR 3.76, 95% CI 2.34-6.06), and low birthweight (pooled OR 2.00, 95% CI 1.42-2.83). SCD was also associated with an increased risk of pre-eclampsia (pooled OR 2.05, 95% CI 1.47-2.85), maternal mortality (pooled OR 10.91, 95% CI 1.83-65.11, P = 0.009), and eclampsia (pooled OR 3.02, 95% CI 1.20-7.58).Conclusion: Pregnancy in women with SCD is associated with increased risks of adverse perinatal and maternal outcomes in both low- and high-income countries.Tweetable Abstract: This meta-analysis showed worse pregnancy outcomes in women with sickle-cell disease compared with controls. [ABSTRACT FROM AUTHOR]

Objective To investigate the risk for preterm birth associated with vaginal infections in pregnancies after a loop electrosurgical excision procedure (LEEP), compared with women with no prior LEEP. Design Multicentre retrospective cohort study. Setting USA. Population Women with LEEP between 1996 and 2006 were compared with two unexposed groups who had cervical biopsy or Pap test, without any other cervical procedure, in the same calendar year. Methods The first pregnancy progressing beyond 20 weeks of gestation in women with prior LEEP was compared with pregnancy in women without LEEP. Stratified analysis according to the presence or the absence of vaginal infection during pregnancy was used to investigate whether the risk for preterm birth differed according to the presence or the absence of infection. The interaction between LEEP and vaginal infection was investigated using multivariable logistic regression with interaction terms, as well as the Mantel-Haenszel test for homogeneity. Main outcome measures Spontaneous preterm birth (<37 and <34 weeks of gestation). Results Of 1727 patients who met the inclusion criteria, 34.4% (n = 598) underwent LEEP prior to an index pregnancy. There was no increased risk for vaginal infections among women with LEEP compared with women without LEEP. Chlamydia infection and LEEP demonstrated significant interaction, suggesting that the presence of chlamydia infection in women with a history of LEEP augments the risk for preterm birth, compared with women with no history of LEEP. Conclusions Vaginal infections during pregnancy in women with a history of LEEP may be associated with an increased risk for preterm birth, compared with women with no history of LEEP. [ABSTRACT FROM AUTHOR]

Objective: To test the hypothesis that use of the Foley bulb plus vaginal misoprostol will result in shorter induction-to-delivery time compared with vaginal misoprostol alone.Methods: We randomized 123 women undergoing induction of labor with singleton pregnancies at 24 weeks of gestation or greater with an unfavorable cervix (Bishop score 6 or lower) to Foley bulb plus vaginal misoprostol (n=56) or vaginal misoprostol alone (n=61). Women with fetal malpresentation, multifetal gestation, spontaneous labor, contraindication to prostaglandins, nonreassuring fetal heart rate tracing, intrauterine growth restriction, anomalous fetus, fetal demise, or previous cesarean delivery or other significant uterine surgery were excluded. The primary outcome measure was induction-to-delivery time. Secondary outcomes were mode of delivery, tachysystole with fetal decelerations, terbutaline use, postpartum hemorrhage, chorioamnionitis, neonatal Apgar scores, and neonatal intensive care unit admission. Analysis followed the intention-to-treat principle.Results: The mean induction-to-delivery time was shorter with the combination of the Foley bulb and vaginal misoprostol when compared with vaginal misoprostol alone (15.3±6.5 compared with 18.3±8.7 hours, difference -3.1 hours, 95% confidence interval [CI] -5.9 to -0.30). The combination also resulted in shorter induction to complete cervical dilation time (13.7±5.9 compared with 17.1±8.7 hours, difference -3.5 hours, 95% CI -6.7 to -0.4). There were no differences in labor complications or adverse neonatal and maternal outcomes.Conclusion: A combination of the Foley bulb and vaginal misoprostol resulted in a shorter induction-to-delivery time when compared with vaginal misoprostol alone without increasing labor complications.Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01279343.Level Of Evidence: I. [ABSTRACT FROM AUTHOR]

Introduction: Markers of placental dysfunction are used for risk prediction of adverse obstetric outcomes including preeclampsia and growth restriction. Although medically indicated preterm birth is often distinguished from spontaneous preterm birth, we hypothesize that similar placental dysfunction may underlay all preterm birth. We aimed to investigate whether first trimester placental protein 13 (PP-13), pregnancy associated plasma protein A (PAPP-A) and uterine artery pulsatility index, with maternal characteristics could be used to predict all preterm birth.Methods: Prospective cohort study of singleton gestations between 11 and 14 weeks who underwent serum measurement of PP-13, PAPP-A, and measurement of uterine artery Doppler pulsatility index. Primary outcomes were preterm birth (PTB) at less than 37 and 33 weeks. Analysis performed both including and excluding preeclampsia to assess the utility of the predictors for all types of preterm birth. Predictive models assembled using logistic regression with each predictor alone and in combination, along with maternal characteristics. Predictive utility of models was assessed using receiver operating curve (ROC) analysis and sensitivities for fixed false positive values.Results: Of 471 women, PTB occurred in 12.5% and early PTB (<33 weeks) occurred in 4.7%. PP-13 was decreased in PTB <37 weeks. PAPP-A was decreased in a dose-response pattern for PTB at <37 weeks and <33 weeks. Uterine artery pulsatility index was increased in early PTB. All patterns of predictors remained the same whether patients with preeclampsia were excluded or included suggesting predictive utility for all causes of PTB. Predictive models all demonstrated good predictive ability with ROC ≥ 0.90.Conclusions: PP-13, PAPP-A, and uterine artery Doppler pulsatility index obtained in the first trimester are good predictors of all types of preterm birth, both indicated and spontaneous. Models including first trimester markers combined with maternal characteristics demonstrated good predictive ability and could be investigated for application of targeted prophylactic strategies. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficiency of first-trimester fetal growth restriction (FGR), low pregnancy-associated plasma protein A (PAPP-A), and their combination for predicting small for gestational age (SGA) at delivery. Methods: Retrospective cohort study of women undergoing first-trimester aneuploidy screening. Fetal crown-rump lengths (CRLs) were at 10 to 14 weeks' gestation and converted to gestational age adjusted Z-scores. Low PAPP-A was defined as levels<5th percentile for GA. Receiver-operating characteristic curves were used to assess screening efficiencies. Results: Among 3269 pregnancies meeting the inclusion criteria 185 (5.7%) infants were SGA. CRL Z-score< -1.0 standard deviation was identified as the optimal definition of early FGR. Using either CRL Z-score< -1.0 standard deviation or PAPP-A<5th percentile had the highest sensitivity (33%) with a specificity of 82.1% when screening for SGA. Using a combination resulted in an increased association (adjusted odds ratio 4.23[confidence interval 1.37-13.03]) at the expense of significantly reduced sensitivity (3.13%). Conclusions: First-trimester FGR and PAPP-A<5th percentile are associated with delivery of an SGA infant. Neither of these parameters or the combination of the two are sufficient powerful predictors of SGA to be clinically useful screening tools. [ABSTRACT FROM AUTHOR]

Objective: To estimate the association between subchorionic hematoma and adverse perinatal outcomes.Data Sources: MEDLINE, EMBASE, and the Cochrane Library.Methods Of Study Selection: We searched English language publications from January 1981 to August 2010 for cohort and case-control studies evaluating subchorionic hematoma and perinatal outcomes. The primary outcome was pregnancy loss (spontaneous abortion and stillbirth). Secondary outcomes were abruption, preterm premature rupture of membranes, preterm delivery, pre-eclampsia, and small for gestational age. Pooled odds ratios (ORs) were calculated from random effects models. TABULATION, INTEGRATION, RESULTS: Seven studies including 1,735 women with subchorionic hematoma and 70,703 controls met inclusion criteria. Subchorionic hematoma was associated with an increased risk of spontaneous abortion (from 8.9% to 17.6%; pooled OR 2.18, 95% confidence interval [CI] 1.29-3.68) and stillbirth (from 0.9% to 1.9%, pooled OR 2.09, 95% CI 1.20-3.67). The number needed to harm was 11 for spontaneous abortion and 103 for stillbirth, meaning one extra spontaneous abortion is estimated to occur for every 11 women with subchorionic hematoma diagnosed and one extra stillbirth occurs for every 103 women with subchorionic hematoma diagnosed. Women with subchorionic hematoma were also at increased risk of abruption (from 0.7% to 3.6%, pooled OR 5.71, 95% CI 3.91-8.33), preterm delivery (from 10.1% to 13.6%, pooled OR 1.40, 95% CI 1.18-1.68), and preterm premature rupture of membranes (from 2.3% to 3.8%, pooled OR 1.64, 95% CI 1.22-2.21), but not small for gestational age (OR 1.69, 95% CI 0.89-3.19) or pre-eclampsia (OR 1.47, 95% CI 0.37-5.89). The numbers needed to harm were 34, 28, and 69 for abruption, preterm delivery, and preterm premature rupture of membranes, respectively.Conclusion: Subchorionic hematoma is associated with an increased risk of early and late pregnancy loss, abruption, and preterm premature rupture of membranes. [ABSTRACT FROM AUTHOR]

Objective: To estimate whether staples or subcuticular suture closure is associated with a higher risk of wound complications when used for transverse skin incisions after cesarean delivery.Data Sources: A systematic review and meta-analysis were performed through electronic database searches (MEDLINE, Cochrane, and Trial Registries).Methods Of Study Selection: We searched electronic databases from 1966 to September 2010 for randomized controlled trials (RCTs) and prospective cohort studies comparing staples to subcuticular sutures after cesarean delivery. The primary outcome was occurrence of a wound complication (infection or separation). Secondary outcomes were components of the composite outcome, operating time, postoperative pain, cosmesis, and patient satisfaction. Heterogeneity was assessed using the χ test for heterogeneity, and I test. Pooled odds ratios (ORs) were calculated using a fixed-effects model. We assessed publication bias using funnel plots and Egger test.Results: Six studies met inclusion criteria: five RCTs and one prospective cohort study. Staple closure (n=803) was associated with a twofold higher risk of wound infection or separation compared with subcuticular suture closure (n=684) (13.4% versus 6.6%, pooled OR 2.06, 95% confidence interval [CI] 1.43-2.98). The number needed to harm associated with staple closure was 16. The increased risk persisted when analysis was limited to the RCTs (OR 2.43, 95% CI 1.47-4.02). There was no evidence of significant statistical heterogeneity among studies (χ=0.74, P=.327, I=13.7%) or publication bias (Egger test, t=-0.86, P=.439). Staple closure was associated with shorter duration of surgery, whereas the two techniques appeared equivalent overall with regard to pain, cosmesis, and patient satisfaction.Conclusion: Staple closure is faster to perform but associated with a higher risk of wound complications. [ABSTRACT FROM AUTHOR]

Strain elastography and shear wave elastography are commonly used to quantify cervical elasticity. However, the absence of stress information in strain elastography causes difficulty in inter-session elasticity comparison, and the robustness of shear wave elastography is compromised by cervical tissue's high inhomogeneity., Objective: To overcome these limitations, we develop a quantitative cervical elastography system by adding a stress sensor to a clinically used transvaginal ultrasound imaging system., Methods: We record the cervical deformation in B-mode images and measure the probe-surface stress through the sensor. Then we quantify the strain using a customized algorithm and estimate the cervical Young's modulus through stress-strain linear regression., Results: In phantom experiments, we demonstrate the system's high accuracy (alignment with the quasi-static compression method, p-value = 0.369 > 0.05), robustness (alignment between 60°- and 90°-contact measurements, p-value = 0.638 > 0.05), repeatability (consistency of single sonographers' measurements, coefficient of variation < 0.06), and reproducibility (alignment between two sonographers' measurements, Pearson correlation coefficient = 0.981). Applying it to pregnant participants, we observe significant cervical softening (p-value < 0.001): Young's modulus decreases 3.95% weekly and its geometric mean value during the first (11 to 13 weeks), second, and third trimesters are 13.07 kPa, 7.59 kPa, and 4.40 kPa, respectively., Conclusion: The proposed system is accurate, robust, and safe, and enables longitudinal and inter-examiner comparisons., Significance: The system applies to different ultrasound machines with minor software updates, which allows for studies of cervical softening patterns in pregnancy for larger populations, facilitating insights into conditions such as preterm birth.

Background: The Chronic Hypertension and Pregnancy Study demonstrated that a target blood pressure of <140/90 mm Hg during pregnancy is associated with improved perinatal outcomes. Outside of pregnancy, pharmacologic therapy for patients with diabetes and hypertension is adjusted to a target blood pressure of <130/80 mm Hg. During pregnancy, patients with both diabetes and chronic hypertension may also benefit from tighter control with a target blood pressure <130/80 mm Hg., Objective: We compared perinatal outcomes in patients with hypertension and diabetes who achieved blood pressure <130/80 vs 130 to 139/80 to 89 mm Hg., Study Design: This was a secondary analysis of a multcenter randomized controlled trial. Participants were included in this secondary analysis if they had diabetes diagnosed prior to pregnancy or at <20 weeks of gestation and at least 2 recorded blood pressure measurements prior to delivery. Average systolic and diastolic blood pressure were calculated using ambulatory antenatal blood pressures. The primary composite outcome was preeclampsia with severe features, indicated preterm birth <35 weeks, or placental abruption. Secondary outcomes were components of the primary outcome, cesarean delivery, fetal or neonatal death, neonatal intensive care unit admission, and small for gestational age. Comparisons were made between those with an average systolic blood pressure <130 mm Hg and average diastolic blood pressure <80 mm Hg and those with an average systolic blood pressure 130 to 139 mm Hg or diastolic blood pressure 80 to 89 mm Hg using Student's t test and chi-squared tests. Multivariable log-binomial regression models were used to evaluate risk ratios between blood pressure groups for dichotomous outcomes while accounting for baseline covariates., Results: Of 434 participants included, 150 (34.6%) had an average blood pressure less than 130/80 mm Hg. Participants with an average blood pressure less than 130/80 were more likely to be on antihypertensive medications at the start of pregnancy and more likely to have newly diagnosed diabetes mellitus prior to 20 weeks. Participants with an average blood pressure less than 130/80 mm Hg were less likely to have the primary adverse perinatal outcome (19.3% vs 46.5%, adjusted relative risk 0.43, 95% confidence interval 0.30-0.61, P<.01), with decreased risks specifically of preeclampsia with severe features (adjusted relative risk 0.35, 95% confidence interval 0.23-0.54) and indicated preterm birth prior to 35 weeks (adjusted relative risk 0.44, 95% confidence interval 0.24-0.79). The risk of neonatal intensive care unit admission was lower in the lower blood pressure group (adjusted relative risk 0.74, 95% confidence interval 0.59-0.94). No differences were noted in cesarean delivery (adjusted relative risk 1.04, 95% confidence interval 0.90-1.20), fetal or neonatal death (adjusted relative risk 0.59, 95% confidence interval 0.12-2.92). Small for gestational age less than the 10th percentile was lower in the lower blood pressure group (adjusted relative risk 0.37, 95% confidence interval 0.14-0.96)., Conclusion: In those with chronic hypertension and diabetes prior to 20 weeks, achieving an average goal blood pressure of <130/80 mm Hg may be associated with improved perinatal outcomes., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To determine maternal and neonatal outcomes in individuals with iron deficiency receiving antepartum intravenous (IV) iron supplementation, stratified by the degree of anemia., Study Design: Retrospective cohort study of iron-deficient pregnant patients who received at least one IV infusion of iron (iron sucrose, low molecular weight iron dextran [LMWID], or ferric carboxymaltose) during their pregnancy from January 1, 2011 through June 16, 2022. Our primary outcomes included both neonatal composite morbidity and maternal composite morbidity in the context of maternal anemia., Results: Patients who received LMWID had fewer infusion visits, received higher total doses of iron and had a more substantial correction of hemoglobin compared to those who received iron sucrose (p < 0.01). Maternal anemia at the time of admission was not associated with neonatal composite morbidity. However, there was a significant association between anemia status and maternal composite outcome (p = 0.05). Anemia at time of delivery was associated with the likelihood of requiring a blood transfusion (p = 0.01)., Conclusion: This study reinforces previous findings emphasizing the adverse effects of iron deficiency on maternal health and the role of IV iron in reducing these risks., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objective: To determine intrapartum factors associated with perineal laceration at delivery., Methods: This was a planned secondary analysis of a multicenter randomized clinical trial of delayed versus immediate pushing among term nulliparous women in labor with neuraxial analgesia conducted in the United States. Intrapartum characteristics were extracted from the medical charts. The primary outcome was perineal laceration, defined as second degree or above, characterized at delivery in women participating in longer term pelvic floor assessments post-delivery. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, birth weight, and maternal age., Results: Among the 941 women participating in the pelvic floor follow-up, 40.6% experienced a perineal laceration. No first stage labor characteristics were associated with perineal laceration, including type of labor or length of first stage. Receiving an amnioinfusion appeared protective of perineal laceration (adjusted odds ratio, 0.48; 95% confidence interval 0.26-0.91; P = 0.01). Second stage labor characteristics associated with injury were length of stage (2.01 h vs. 1.50 h; adjusted odds ratio, 1.36; 95% confidence interval 1.18-1.57; P < 0.01) and a prolonged second stage (adjusted odds ratio, 1.64; 95% confidence interval 1.06-2.56; P < 0.01). Operative vaginal delivery was strongly associated with perineal laceration (adjusted odds ratio, 3.57; 95% confidence interval 1.85-6.90; P < 0.01)., Conclusion: Operative vaginal delivery is a modifiable risk factor associated with an increased risk of perineal laceration. Amnioinfusion appeared protective against injury, which could reflect a spurious finding, but may also represent true risk reduction similar to the mechanism of warm perineal compress., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: Remote self-measured blood pressure (SMBP) programs improve racial health equity among postpartum people with hypertensive disorders of pregnancy (HDP) who receive recommended blood pressure ascertainment after hospital discharge.1-3 However, as prior studies have been conducted within racially diverse but ethnically homogeneous populations,1-3 the effect of SMBP programs on ethnicity-based inequities is less understood.4 We examined whether SMBP rates differed among Hispanic versus non-Hispanic participants in remote SMBP programs., Study Design: This is a planned secondary analysis of a RCT conducted among postpartum patients with HDP who were enrolled into our remote SMBP program, in which they obtain SMBP and then manually enter the SMBP value into a patient portal for individual provider response. In the parent trial, consenting patients were randomized to continued manual blood pressure entry of SMBP or use of a Bluetooth-enabled blood pressure cuff synched to a smartphone application utilizing artificial intelligence to respond to each obtained blood pressure or symptom for six weeks and to flag abnormalities for providers. Both SMBP programs were available in Spanish and English. For this study, women who self-reported their ethnicity were stratified into two ethnic groups - Hispanic and non-Hispanic - regardless of randomization group. Those who did not self-report ethnicity but completed all study procedures in Spanish were also categorized as Hispanic. Outcomes were the same in the parent study and this secondary analysis. The primary outcome was ≥1 SMBP assessment within 10 days postpartum. Secondary outcomes included number of blood pressure assessments and healthcare utilization outcomes (remote antihypertensive medication initiation or dose-increase and presentation to the Emergency Department or readmission for hypertension within 30 days of discharge). Participants rated their experience with SMBP via a scale from 0 (worst possible) to 10 (best possible) and the Decision Regret Scale, which assessed their regret in SMBP program participation (0=no regret; 100=high regret)).5 Outcomes were compared between groups. Risk differences (RD) were calculated for categorical and regression coefficients for continuous outcomes. The parent RCT was IRB-approved and published on clinicaltrials.gov (NCT05595629) before enrollment., Results: Among 119 women in the parent study, 83 (70%) self-reported ethnicity and the proportion of Hispanic people was similar in both treatment groups. This study compared 23 Hispanic (19% monolingual in Spanish) to 62 non-Hispanic women. Rates of SMBP assessment within 10 days postpartum was similar (Hispanic 64% vs non-Hispanic 79%; RD -0.1 (95% Confidence Interval (CI) -0.4, 0.1). There were no differences in mean number of remote SMBP assessments or rates of remote antihypertensive medication initiation or dose titration. The rates of hypertension-related presentations to the Emergency Department or hospital readmission were also similar between groups. Lastly, regardless of ethnicity, participants had low scores on the Decision Regret Scale and rated their experience with their remote SMBP program highly favorably. (See Table 1.) Conclusion: Hispanic and non-Hispanic postpartum patients with HDP had similar outcomes and favorable patient perceptions. The small sample size in this study may have produced inadequate power to detect a difference between study groups, thereby leading to Type II error. Thus, more research on Hispanic participants in remote SMBP programs is needed. However, the effect of remote SMBP programs on perinatal equity may not be limited to race-based disparities.

Importance: The associated effect of duration of the second stage of labor (SSL) on pelvic floor symptoms development is not well studied., Objective: This study aimed to examine the association between duration of SSL and pelvic floor symptoms at 6 months postpartum among primiparous women., Study Design: A planned secondary analysis of a multicenter randomized trial evaluating the impact of immediate versus delayed pushing on vaginal delivery rates, maternal morbidity, and neonatal outcomes was conducted between 2014 and 2018. For pelvic floor arm participants, demographic, pelvic examination, and validated questionnaire data were collected postpartum. Primary outcome was change in Pelvic Floor Distress Inventory 20 (PFDI-20) score from immediate to 6 months postpartum. Secondary outcomes included changes in the Pelvic Floor Impact Questionnaire, Fecal Incontinence Severity Index, Modified Manchester Health Questionnaire scores, and Pelvic Organ Prolapse Quantification measurements at 6 months postpartum. Participants were analyzed by SSL duration ≤60 minutes or >60 minutes., Results: Of the 2,414 trial participants, 767 (32%) completed pelvic floor assessments at 6 months. Pelvic Floor Distress Inventory 20 scores significantly improved at 6 months in the ≤60 minutes SSL group compared with >60 minutes SSL (-14.3 ± 48.0 and -3.2 ± 45.3, respectively; P = 0.04). Changes from immediate postpartum in total and subscale scores for other questionnaires at 6 months did not differ between groups. Prolapse stage did not differ between groups. Perineal body was significantly shorter in the >60 minutes SSL group (3.7 ± 0.7, 3.5 ± 0.8; P = 0.03)., Conclusions: Women with SSL >60 minutes experience less improvement in PFDI-20 scores at 6 months. Greater tissue and innervation trauma in those with SSL >60 minutes may explain persistently less improvement in PFDI-20 scores., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)

Introduction: The prevalence of both obesity and gestational diabetes mellitus (GDM) has increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy and caesarean delivery. Women with GDM who are also overweight or obese have higher rates of pregnancy complications when compared with normal-weight women with GDM, which may occur in part due to suboptimal glycaemic control. The current recommendations for glycaemic targets in pregnant women with diabetes are based on limited evidence and exceed the mean fasting (70.9±7.8 mg/dL) and 1-hour postprandial (108.9±12.9 mg/dL) glucose values in pregnant individuals without diabetes. Our prior work demonstrated that the use of intensive (fasting <90 mg/dL and 1-hour postprandial <120 mg/dL) compared with standard (fasting <95 mg/dL and 1-hour postprandial <140 mg/dL) glycaemic targets resulted in improved glycaemic control without increasing the risk for hypoglycaemia in pregnant individuals with GDM, but the impact of intensive glycaemic targets on perinatal outcomes is unknown., Methods and Analysis: The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomised clinical trial designed to investigate the impact of intensive versus standard glycaemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from five medical centres representing regions of the USA with high rates of obesity will randomise 828 overweight and obese women with GDM to either intensive or standard glycaemic targets. We will test the central hypothesis that intensive glycaemic targets will result in lower rates of neonatal composite morbidity including large for gestational age birth weight, neonatal hypoglycaemia, respiratory distress syndrome and need for phototherapy when compared with standard glycaemic targets using the intention-to-treat approach to analysis., Ethics and Dissemination: The Institutional Review Board (IRB) at Indiana University School of Medicine approved this study (IRB# 11435; initial approval date 25 August 2021). We will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings., Trial Registration Number: NCT05124808., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed to examine the effect of digital health interventions compared with treatment as usual on preventing and treating postpartum depression and postpartum anxiety., Data Sources: Searches were conducted in Ovid MEDLINE, Embase, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov., Study Eligibility Requirements: The systematic review included full-text randomized controlled trials comparing digital health interventions with treatment as usual for preventing or treating postpartum depression and postpartum anxiety., Study Appraisal and Synthesis Methods: Two authors independently screened all abstracts for eligibility and independently reviewed all potentially eligible full-text articles for inclusion. A third author screened abstracts and full-text articles as needed to determine eligibility in cases of discrepancy. The primary outcome was the score on the first ascertainment of postpartum depression or postpartum anxiety symptoms after the intervention. Secondary outcomes included screening positive for postpartum depression or postpartum anxiety --as defined in the primary study --and loss to follow-up, defined as the proportion of participants who completed the final study assessment compared with the number of initially randomized participants. For continuous outcomes, the Hedges method was used to obtain standardized mean differences when the studies used different psychometric scales, and weighted mean differences were calculated when studies used the same psychometric scales. For categorical outcomes, pooled relative risks were estimated., Results: Of 921 studies originally identified, 31 randomized controlled trials-corresponding to 5532 participants randomized to digital health intervention and 5492 participants randomized to treatment as usual-were included. Compared with treatment as usual, digital health interventions significantly reduced mean scores ascertaining postpartum depression symptoms (29 studies: standardized mean difference, -0.64 [95% confidence interval, -0.88 to -0.40]; I 2 =94.4%) and postpartum anxiety symptoms (17 studies: standardized mean difference, -0.49 [95% confidence interval, -0.72 to -0.25]; I 2 =84.6%). In the few studies that assessed screen-positive rates for postpartum depression (n=4) or postpartum anxiety (n=1), there were no significant differences between those randomized to digital health intervention and treatment as usual. Overall, those randomized to digital health intervention had 38% increased risk of not completing the final study assessment compared with those randomized to treatment as usual (pooled relative risk, 1.38 [95% confidence interval, 1.18-1.62]), but those randomized to app-based digital health intervention had similar loss-to-follow-up rates as those randomized to treatment as usual (relative risk, 1.04 [95% confidence interval, 0.91-1.19])., Conclusion: Digital health interventions modestly, but significantly, reduced scores assessing postpartum depression and postpartum anxiety symptoms. More research is needed to identify digital health interventions that effectively prevent or treat postpartum depression and postpartum anxiety but encourage ongoing engagement throughout the study period., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Anemia is common during pregnancy, and while most anemia is physiologic, the most common pathologic cause is iron deficiency. The American College of Obstetricians and Gynecologists (ACOG) recommends confirmation of iron deficiency anemia with iron studies when anemia is diagnosed during pregnancy but acknowledges that presumptive treatment for suspected iron deficiency anemia is common in practice. Currently ACOG does not recommend treating iron deficiency without anemia during pregnancy. Though the benefits of treating iron deficiency anemia during pregnancy are clear, the optimal route of iron repletion remains uncertain. Results of ongoing large, randomized trials will help define the optimal route of iron treatment for pregnant patients diagnosed with iron deficiency anemia., (Copyright © 2023 by The American Society of Hematology.)

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.)

Postpartum hemorrhage , defined as a cumulative blood loss of 1,000 mL or more or blood loss associated with signs or symptoms of hypovolemia regardless of the route of delivery, is the leading cause of preventable maternal death worldwide. The United States has one of the highest maternal mortality rates among developed countries, with about 14% of all maternal deaths associated with postpartum hemorrhage. Although postpartum hemorrhage has multiple causes, the most common is uterine atony-when the uterus fails to adequately contract after childbirth-accounting for 80% of all postpartum hemorrhages. When postpartum hemorrhage occurs despite preventive measures, therapeutic measures are used. Intrauterine hemorrhage-control devices are often the second-line therapy when medical management is unsuccessful. Despite its widespread use in current obstetric practice, the mechanism of intrauterine balloon tamponade, such as the Bakri balloon, is counterintuitive to the physiologic uterine contraction that occurs after delivery to control bleeding, and data on its effectiveness are mixed. Vacuum-induced hemorrhage control, such as with the Jada System, cleared by the U.S. Food and Drug Administration in 2020, is a novel modality for control of postpartum bleeding. It mimics postpartum physiology by applying low-level intrauterine negative pressure to facilitate uterine compressive forces, thereby constricting blood vessels to achieve hemostasis. Preliminary data from four studies are promising but are limited by a lack of control groups, selection bias, or modest sample sizes. The results of ongoing and planned randomized controlled trials will clarify the role of the Jada System for reducing morbidity from postpartum hemorrhage., Competing Interests: Financial Disclosure Methodius G. Tuuli reports that money was paid to his prior institution from Alydia Inc for research. Tracy L. Jackson 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.)

Background: Cesarean delivery is the most performed major surgery among women, and surgical-site infections following a cesarean delivery are a significant source of postoperative morbidity. It is unclear if vaginal cleansing before a cesarean delivery decreases post-cesarean delivery infectious morbidity., Objective: This study aimed to evaluate if preoperative vaginal cleansing with povidone-iodine among women undergoing a cesarean delivery after labor decreases postoperative infectious morbidity., Study Design: This randomized clinical trial was conducted from August 3, 2015 to January 28, 2021, with 30 days of follow-up and the final follow-up completed on February 27, 2021. Patients met the inclusion criteria if they underwent a cesarean delivery after regular contractions with cervical dilation, rupture of membranes, or any cesarean delivery performed at >4 cm dilation. Participants were randomly assigned in a 1:1 ratio to either abdominal cleansing plus vaginal cleansing with 1% povidone-iodine or abdominal cleansing alone. The primary outcome was composite infectious morbidity including surgical-site infection, fever, endometritis, and wound complications within 30 days after the cesarean delivery. Secondary outcomes included individual components of the composite, length of hospital stay, postoperative hospitalization or outpatient treatment related to infectious morbidity, and empirical treatment for neonatal sepsis., Results: A total of 608 subjects (304 vaginal cleansing group, 304 control group) were included in the intention-to-treat analysis. Patient characteristics were similar between groups. There was no significant difference in the primary composite outcome between the 2 groups (11.8% vs 11.5%; P=.90; relative risk, 1.0; 95% confidence interval, 0.7-1.6). Individual components of the composite and secondary outcomes were also not significantly different between the groups. Similar findings were observed in the as-treated analysis (11.3% vs 11.8%; P=.9; relative risk, 1.0; 95% confidence interval, 0.7-1.6)., Conclusion: Vaginal cleansing with povidone-iodine before an unscheduled cesarean delivery occurring after labor did not reduce the postoperative infectious morbidity. These findings do not support the routine use of vaginal cleansing for women undergoing a cesarean delivery after labor., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity., Methods: This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1-5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP)., Results: Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P =.01), but less than the minimum important difference of 4., Conclusion: Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum., Clinical Trial Registration: ClinicalTrials.gov , NCT02137200., Competing Interests: Financial Disclosure Methodius G. Tuuli reports that money was paid to his institution from the NIH and the Gates Foundation. Holly E. Richter reports the following: Renovia-research funding (SUI, FI); Up to Date-Royalties; NIA-research funding; NIDDK-research funding; NICHD-research funding; Obstet Gynecol & IUJ, travel reimbursement related to editor duties; Worldwide Fistula Fund, board; DSMB Bluewind; Symposia Medicus-CME speaker. 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: There is wide variation in the management of pregnancies complicated by abnormal placental cord insertion (PCI), which includes velamentous cord insertion (VCI) and marginal cord insertion (MCI). We tested the hypothesis that abnormal PCI is associated with small for gestational age (SGA) infants., Study Design: This is a retrospective cohort study of all pregnant patients undergoing anatomic ultrasound at a single institution from 2010 to 2017. Patients with abnormal PCI were matched in a 1:2 ratio by race, parity, gestational age at the time of ultrasound, and obesity to patients with normal PCIs. The primary outcome was SGA at delivery. Secondary outcomes were cesarean delivery, preterm delivery, cesarean delivery for nonreassuring fetal status, 5-minute Apgar score < 7, umbilical artery pH < 7.1, and neonatal intensive care unit admission. These outcomes were compared using univariate and bivariate analyses., Results: Abnormal PCI was associated with an increased risk of SGA (relative risk [RR]: 2.43; 95% confidence interval [CI]: 1.26-4.69), increased risk of preterm delivery <37 weeks (RR: 3.60; 95% CI: 1.74-7.46), and <34 weeks (RR: 3.50; 95% CI: 1.05-11.63) compared with patients with normal PCI. There was no difference in rates of cesarean delivery, Apgar score of <7 at 5 minutes, acidemia, or neonatal intensive care unit admission between normal and abnormal PCI groups. In a stratified analysis, the association between abnormal PCI and SGA did not differ by the type of abnormal PCI ( p for interaction = 0.46)., Conclusion: Abnormal PCI is associated with an increased risk of SGA and preterm delivery. These results suggest that serial fetal growth assessments in this population may be warranted., Key Points: · Abnormal PCI is associated with SGA infants and preterm birth.. · If an abnormal PCI is identified, the provider should consider serial growth ultrasounds.. · There is no difference in obstetric outcomes between VCI and MCI.., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Each year, nearly 300,000 women and 5 million fetuses or neonates die during childbirth or shortly thereafter, a burden concentrated disproportionately in low- and middle-income countries. Identifying women and their fetuses at risk for intrapartum-related morbidity and death could facilitate early intervention. Methods: The Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR) Study is a multi-country, prospective, observational cohort designed to exhaustively document the course and outcomes of labor, delivery, and the immediate postpartum period in settings where adverse outcomes are frequent. The study is conducted at four hospitals across three countries in Ghana, India, and Zambia. We will enroll approximately 12,000 women at presentation to the hospital for delivery and follow them and their fetuses/newborns throughout their labor and delivery course, postpartum hospitalization, and up to 42 days thereafter. The co-primary outcomes are composites of maternal (death, hemorrhage, hypertensive disorders, infection) and fetal/neonatal adverse events (death, encephalopathy, sepsis) that may be attributed to the intrapartum period. The study collects extensive physiologic data through the use of physiologic sensors and employs medical scribes to document examination findings, diagnoses, medications, and other interventions in real time. Discussion: The goal of this research is to produce a large, sharable dataset that can be used to build statistical algorithms to prospectively stratify parturients according to their risk of adverse outcomes. We anticipate this research will inform the development of new tools to reduce peripartum morbidity and mortality in low-resource settings., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Adu-Amankwah A et al.)

Objective: We tested the hypothesis that administration of vaginal progesterone in women with arrested preterm labor would result in lower rates of preterm birth <37 weeks compared to placebo., Study Design: We performed a randomized, placebo-controlled trial comparing vaginal progesterone to placebo in women with arrested preterm labor. Our trial included women with a singleton or twin gestation at 24 0 /7 weeks' gestation who presented with preterm labor with cervical dilation ≥1 centimeter but remained undelivered. Participants were randomized to receive vaginal progesterone 200 mg daily or an identical placebo. The primary outcome was preterm birth <37 weeks. We performed an updated systematic review and meta-analysis of clinical trials, including our results. We searched MEDLINE, EMBASE, CINHAL, Scopus, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov using the key terms to identify relevant trials. The risk of bias was appraised using the Cochrane risk-of-bias tool. Data were synthesized using random-effects models. Heterogeneity was assessed using Higgins 6/7 weeks' gestation who presented with preterm labor with cervical dilation ≥1 centimeter but remained undelivered. Participants were randomized to receive vaginal progesterone 200 mg daily or an identical placebo. The primary outcome was preterm birth <37 weeks. We performed an updated systematic review and meta-analysis of clinical trials, including our results. We searched MEDLINE, EMBASE, CINHAL, Scopus, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov using the key terms to identify relevant trials. The risk of bias was appraised using the Cochrane risk-of-bias tool. Data were synthesized using random-effects models. Heterogeneity was assessed using Higgins I 2 ., Results: The randomized trial was prematurely terminated due to slow recruitment. There were 18 women randomized to receive vaginal progesterone who had complete follow-up data and 18 women in the placebo group. The risk of preterm birth <37 weeks was not significantly different in the groups (RR 1.10, 95% CI 0.63-1.19). Secondary outcomes were also similar. Thirteen trials with 1658 women (835 in the vaginal progesterone and 823 in the control groups) were included in the meta-analysis. Risk of preterm birth <37 weeks was similar in women who received progesterone and those in the control group (pooled RR 1.06, 95% CI 0.83-1.35). Latency was significantly longer among women with arrested preterm labor who received vaginal progesterone (weighted mean difference: 9.2 d, 95% CI 3.2-15.1), but further analysis showed that prolonged latency was only observed in the subgroup of studies that were not placebo-controlled., Conclusions: This randomized controlled trial and meta-analysis do not support the use of vaginal progesterone for the prevention of preterm birth in women who present in preterm labor.

Background: Iron deficiency anemia (IDA) is common during pregnancy and associated with adverse maternal and neonatal outcomes. Treatment with iron supplementation is recommended during pregnancy, but the optimal delivery route is unclear. Oral iron risks has high risk of gastrointestinal side effects and low absorption. Intravenous iron is infused directly but is expensive. The American College of Obstetricians and Gynecologists currently recommends oral iron to treat IDA in pregnancy with intravenous iron reserved as second-line therapy, if needed. This approach is associated with persistent anemia, increasing the risk of peripartum blood transfusion. We aim to provide data on optimal route of iron repletion for IDA in pregnancy., Methods: In IVIDA2, a double-blind, placebo controlled, multicenter randomized trial in the United States, 746 pregnant people with moderate-to-severe IDA (hemoglobin <10 g/dL and ferritin <30 ng/mL) at 24-28 weeks' gestation will be randomized 1:1 to either a single 1000 mg dose of intravenous ferric derisomaltose and oral placebo (1-3 times daily) or a single placebo infusion with 1-3 times daily 325 mg ferrous sulfate (65 mg elemental iron) tablet. The primary outcome is peripartum blood transfusion (blood transfusion from delivery to 7 days postpartum). Secondary outcomes include adverse medication reactions, maternal and neonatal hematologic indices, and offspring neurodevelopment., Ethics and Dissemination: A central ethical review board-Advarra-granted ethical approval (Pro00060930). Participating centers-Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of Ethics and dissemination: A central ethical review board-Advarra-granted ethical approval (Pro00060930). Participating centers-Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The study is funded by the NICHD (R01 HD105855; PI: Methodius Tuuli) and supported by an unrestricted grant from Pharmacosmos Therapeutics Inc. (MPI: Methodius Tuuli & Adam Lewkowitz). Neither NICHD nor Pharmacosmos Therapeutics, Inc has no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of this manuscript and the decision to submit for publication. The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official view of NICHD or Pharmacosmos Therapeutics Inc., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To estimate short-term maternal and neonatal outcomes with one-compared with two-step testing for gestational diabetes mellitus (GDM)., Data Sources: A systematic review of randomized controlled trials (RCTs) and observational studies comparing one-step and two-step GDM testing strategies before September 2021 was conducted. We searched Ovid Medline (1946-), EMBASE (1947-), Scopus (1960-), Cochrane Central, and ClinicalTrials.gov . The primary outcome was rate of large-for-gestational age (LGA) neonates. Secondary outcomes were clinically relevant outcomes for GDM that were selected a priori., Methods of Study Selection: Titles, abstracts, and manuscripts were screened, selected, and reviewed by the first two authors. Four RCTs (24,966 patients) and 13 observational studies (710,677 patients) were analyzed., Tabulation, Integration, and Results: Pooled relative risks (RRs) were calculated with 95% CIs using random-effects models and were plotted graphically with forest plots. Study heterogeneity was evaluated using Cochran Q and Higgins I 2 tests. The quality of studies that met the inclusion criteria was evaluated with the Downs and Black checklist. Publication bias was assessed by using asymmetry of funnel plots and Harbord's test. There was no difference in the rate of LGA neonates (pooled RR 0.95; 95% CI 0.88-1.04) by testing strategy among RCTs, but patients who underwent one-step testing were more likely to be diagnosed with GDM (pooled RR 2.13; 95% CI 1.61-2.82) and treated with diabetes medications (pooled RR 2.24; 95% CI 1.21-4.15). One-step testing was associated with higher rates of neonatal intensive care unit (NICU) admission (pooled RR 1.12; 95% CI 1.00-1.26) and neonatal hypoglycemia (pooled RR 1.23; 95% CI 1.13-1.34). In analysis of high-quality RCTs and observational studies, one-step testing was associated with a lower rate of LGA neonates (pooled RR 0.97; 95% CI 0.95-0.98), but higher rates of GDM diagnosis, treatment, NICU admission, and neonatal hypoglycemia., Conclusion: Despite a significant increase in GDM diagnosis and treatment with one-step testing, there is no difference in rate of LGA neonates compared with two-step testing among RCTs., Systematic Review Registration: PROSPERO, CRD42021252703., Competing Interests: Financial Disclosure Jeannie C. Kelly reports that money was paid to her institution from PEW, the Barnes Jewish Foundation, and Doris Duke. Ebony Carter's institution received payment from the American Diabetes Association NIH/NIMH Robert Wood Johnson Foundation. She received payment as part of Carter Expert Strategic Consulting and from Affinia Healthcare (board advisor, Mother Goose). 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.)

Background: Pregnancy and childbirth are known risk factors associated with the development of pelvic organ prolapse; specific intrapartum risk factors are not well characterized., Objective: This study aimed to determine intrapartum factors associated with increased risk of pelvic organ prolapse identified after delivery., Study Design: A planned secondary analysis of a multicenter randomized clinical trial of delayed vs immediate pushing among nulliparous women at ≥37 weeks of gestation in labor with neuraxial analgesia was conducted at 6 academic and community hospitals in the United States. Intrapartum characteristics were identified, and Pelvic Organ Prolapse Quantification assessments at 6 weeks and 6 months after delivery were performed. The primary outcome was pelvic organ prolapse, defined as stage 2 or greater prolapse using the Pelvic Organ Prolapse Quantification assessment at 6 months. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, macrosomia, and maternal age., Results: Among the 941 women participating in the pelvic floor follow-up, 793 women had Pelvic Organ Prolapse Quantification assessments at 6 weeks with 91 of 793 women (11.5%) demonstrating stage 2 or greater prolapse. Of the 728 women followed up at 6 months, stage 2 or greater prolapse was identified in 58 of 728 women (8.0%). Prostaglandin use for induction of labor was associated with an increased risk at 6 months (adjusted odds ratio, 2.15; 95% confidence interval, 1.18-3.91; P<.01). The length and type (spontaneous vs induced) of the first stage of labor were not significantly associated with stage 2 or greater prolapse. Moreover, increased length of the second stage of labor and duration of pushing were not associated with stage 2 or greater prolapse. After adjusting for confounding factors, cesarean delivery was protective of pelvic organ prolapse at 6 months (adjusted odds ratio, 0.12; 95% confidence interval, 0.02-0.90)., Conclusion: The management of the first and second stages of labor, including time length, was not associated with stage 2 or greater prolapse at 6 months. The findings that prostaglandin exposure was associated with increased risk likely were not directly affecting the risk of prolapse but may be surrogates for other labor features that deserve exploration. Cesarean delivery was associated with protection from stage 2 or greater pelvic organ prolapse at 6 months, consistent with previous literature., (Copyright © 2022 Elsevier Inc. All rights reserved.)

The objective of this study was to evaluate maternal outcomes with an extended second stage of labor and determine if an extended second stage is cost effective. This theoretical model evaluated expectant management to 4 h compared to delivery at 3 h in the setting of a prolonged second stage of labor in nulliparous women with epidural analgesia. In our theoretical cohort of 165,000 women, we found that an extended second stage resulted in 53,268 more spontaneous vaginal deliveries, 14,163 fewer operative vaginal deliveries, and 39,105 fewer cesarean deliveries. This approach also resulted in 1 fewer instance of maternal death. An extended second stage, however, led to 14,025 more cases of chorioamnionitis, 1699 more episodes of postpartum hemorrhage requiring transfusion, and 119 more severe perineal lacerations, suggesting that while an extended second stage of labor results in overall improved maternal outcomes, there are tradeoffs. Expectant management to 4 h was the dominant strategy in the model, as it saved over $114 million US dollars and resulted in 4000 additional QALYs over our theoretical cohort. Sensitivity analysis indicated that expectant management until 4 h was cost-effective as long as the probability of cesarean delivery at 4 h was below 41.8%, and was the dominant strategy below 38.2% (baseline input: 19.5%). Multivariable sensitivity analysis demonstrated that the model was robust over a wide range of assumptions. Expectant management of the second stage of labor until 4 h is a cost-effective strategy to prevent primary cesarean deliveries, decrease costs, and improve some maternal outcomes, despite tradeoffs.

Background: Worldwide, 10% of babies are born preterm, defined as a live birth before 37 weeks of gestation. Preterm birth is the leading cause of neonatal death, and survivors face lifelong risks of adverse outcomes. New approaches with large sample sizes are needed to identify strategies to predict and prevent preterm birth. The primary aims of the Washington University Prematurity Research Cohort Study were to conduct three prospective projects addressing possible causes of preterm birth and provide data and samples for future research., Study Design: Pregnant patients were recruited into the cohort between January 2017 and January 2020. Consenting patients were enrolled into the study before 20 weeks' gestation and followed through delivery. Participants completed demographic and lifestyle surveys; provided maternal blood, placenta samples, and cord blood; and participated in up to three projects focused on underlying physiology of preterm birth: cervical imaging (Project 1), circadian rhythms (Project 2), and uterine magnetic resonance imaging and electromyometrial imaging (Project 3)., Results: A total of 1260 participants were enrolled and delivered during the study period. Of the participants, 706 (56%) were Black/African American, 494 (39%) were nulliparous, and 185 (15%) had a previous preterm birth. Of the 1260 participants, 1220 (97%) delivered a live infant. Of the 1220 with a live birth, 163 (14.1%) had preterm birth, of which 74 (6.1%) were spontaneous preterm birth. Of the 1220 participants with a live birth, 841 participated in cervical imaging, 1047 contributed data and/or samples on circadian rhythms, and 39 underwent uterine magnetic resonance imaging. Of the 39, 25 underwent electromyometrial imaging., Conclusion: We demonstrate feasibility of recruiting and retaining a diverse cohort in a complex prospective, longitudinal study throughout pregnancy. The extensive clinical, imaging, survey, and biologic data obtained will be used to explore cervical, uterine, and endocrine physiology of preterm birth and can be used to develop novel approaches to predict and prevent preterm birth., Competing Interests: The authors have declared that no competing interests exist.

Objective: Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA., Study Design: This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol., Results: The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p  = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p  = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups., Conclusion: IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227., Key Points: · IV iron decreases rates of anemia on admission for delivery compared with oral iron.. · In an unblinded randomized trial, a significant proportion of patients preferred alternate therapy.. · Future RCTs should incorporate double-blinded technique to reduce risk of patient crossover.. · Results from feasibility trial support a larger RCT comparing IV to oral iron for IDA in pregnancy.., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Evidence of detachment of the levator ani muscle system is seen more frequently in patients with pelvic floor disorders. It has been suggested that passive descent of the fetus before pushing could be used to decrease operative vaginal delivery and levator ani muscle injury., Objective: This planned analysis aimed to determine whether immediate or delayed pushing was associated with an increased proportion of injury to the levator ani muscle system after the first delivery among nulliparous women., Study Design: The Optimizing Management of the Second Stage study was a multicenter randomized trial. Nulliparous women with term pregnancies and neuraxial analgesia were randomly assigned at complete cervical dilation to either immediate pushing or delayed pushing for 1 hour. A subset of participants consented to longitudinal objective pelvic floor assessments: (1) during postpartum stay (initial), (2) at 6 weeks (postpartum 1), and (3) at 6 months (postpartum 2) with transperineal 3-dimensional ultrasound. Following the completion of all visits by all subjects, saved 3-dimensional ultrasound volumes were assessed in a masked fashion. The outcome was "occult" levator ani muscle injury on the right or left, defined as a widening of the attachment of the levator ani to its origin utilizing the levator-urethra gap measurement. Measurements and proportions were compared between the 2 groups by study visit using the χ 2 test or Fisher exact test for categorical variables and the t test or Mann-Whitney U test for continuous variables as appropriate., Results: Here, 941 of 2414 randomized subjects (39.0%) participated in the pelvic floor assessments: 452 in the immediate pushing group and 489 in the delayed pushing group. We obtained sonograms on 67%, 83%, and 77% of the pelvic floor assessment participants at the initial, postpartum 1, and postpartum-2 visits, respectively. Demographic and labor characteristics were comparable between the 2 groups; 94% of participants were non-Hispanic, and 50% of participants were Black. Levator ani muscle injury was noted in 77 participants (13.6%) at the initial visit, 99 (13.1%) at PP1, and 72 (10.6%) at PP2. There was no difference in injury between women in the immediate pushing group and women in the delayed pushing group. These findings did not change when the threshold (sensitivity) of levator ani muscle injury was adjusted to a less conservative measure., Conclusion: Among nulliparous women at term with neuraxial analgesia, the rates of occult levator ani muscle injury were not different between women undergoing immediate pushing and women undergoing delayed pushing in the second stage of labor. Further research efforts are needed to understand the development and potential prevention of subsequent pelvic floor disorders., (Copyright © 2022 Elsevier Inc. All rights reserved.)