Quantification of Cervical Elasticity During Pregnancy Based on Transvaginal Ultrasound Imaging and Stress Measurement.

Strain elastography and shear wave elastography are two commonly used methods to quantify cervical elasticity. However, the absence of stress information in strain elastography causes difficulty in comparing elasticities acquired in different sessions, and the robustness of shear wave elastography tends to be compromised by the high inhomogeneity of cervical tissue. 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: In an imaging session, we use the ultrasound system to record the cervical deformation in B-mode images and use the stress sensor to record the probe-surface stress simultaneously. We develop a feature-tracking algorithm to quantify the deformation automatically and calculate the strain. Then we estimate the cervical Young's modulus through stress-strain linear regression. RESULTS: In phantom experiments, we demonstrate the elastography 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 softening of the cervix during pregnancy (p-value < 0.001) with the cervical Young's modulus decreasing 3.95% per week. We estimate that geometric mean values of cervical Young's moduli 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 measurements and comparisons between examiners. 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.

First and Second Stage Risk Factors Associated with Perineal Lacerations.

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.

Impact of the Duration of the Second Stage of Labor on Postpartum Pelvic Floor Symptoms.

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.

Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study.

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.

The effect of digital health interventions on postpartum depression or anxiety: a systematic review and meta-analysis of randomized controlled trials.

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]; I2=94.4%) and postpartum anxiety symptoms (17 studies: standardized mean difference, -0.49 [95% confidence interval, -0.72 to -0.25]; I2=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.

Identifying and treating iron deficiency anemia in pregnancy.

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.

Intrauterine Postpartum Hemorrhage-Control Devices.

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.

Perinatal Outcomes Associated With Management of Stage 1 Hypertension.

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.

Effect of Second-Stage Pushing Timing on Postpartum Pelvic Floor Morbidity: A Randomized Controlled Trial.

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.

Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial.

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.

Obstetric Outcomes in Singleton Pregnancies with Abnormal Placental Cord Insertions.

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..

Protocol for a multicenter, double-blinded placebo-controlled randomized controlled trial comparing intravenous ferric derisomaltose to oral ferrous sulfate for the treatment of iron deficiency anemia in pregnancy: The IVIDA2 trial.

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.

One-Step Compared With Two-Step Gestational Diabetes Screening and Pregnancy Outcomes: A Systematic Review and Meta-analysis.

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.

A multidisciplinary Prematurity Research Cohort Study.

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.

Intrapartum risk factors associated with pelvic organ prolapse at 6 months postpartum.

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.