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Summary Background Women with HIV face an increased risk of preterm birth. 17 alpha-hydroxyprogesterone caproate (17P) has been shown in some trials to reduce early delivery among women with a history of spontaneous preterm birth. We investigated whether 17P would reduce this risk among women with HIV. Methods We did a randomised, double-blind, placebo-controlled trial in pregnant women with HIV at the University Teaching Hospital and Kamwala District Health Centre in Lusaka, Zambia. Eligible patients were women aged 18 years or older with confirmed HIV-1 infection, viable intrauterine singleton pregnancy at less than 24 weeks of gestation, and were receiving or intending to commence antiretroviral therapy during pregnancy. Exclusion criteria were major uterine or fetal anomaly; planned or in situ cervical cerclage; evidence of threatened miscarriage, preterm labour, or ruptured membranes at screening; medical contraindication to 17P; previous participation in the trial; or history of spontaneous preterm birth. Eligible participants provided written informed consent and were randomly assigned (1:1) to receive 250 mg intramuscular 17P or placebo once per week, starting between 16 and 24 weeks of gestation until delivery, stillbirth, or reaching term (37 weeks). Participants and study staff were masked to assignment, except for pharmacy staff who did random assignment and prepared injections but did not interact with participants. The primary outcome was a composite of delivery before 37 weeks or stillbirth at any gestational age. Patients attended weekly visits for study drug injections and antenatal care. We estimated the absolute and relative difference in risk of the primary outcome and safety events between treatment groups by intention to treat. This trial is registered with ClinicalTrials.gov , NCT03297216 , and is complete. Findings Between Feb 7, 2018 and Jan 13, 2020, we assessed 1042 women for inclusion into the study. 242 women were excluded after additional assessments, and 800 eligible patients were enrolled and randomly assigned to receive intramuscular 17P (n=399) or placebo (n=401). Baseline characteristics were similar between groups. Adherence to study drug injections was 98% in both groups, no patients were lost to follow-up, and the final post-partum visit was on Aug 6, 2020. 36 (9%) of 399 participants assigned to 17P had preterm birth or stillbirth, compared with 36 (9%) of 401 patients assigned to placebo (risk difference 0·1, 95% CI −3·9 to 4·0; relative risk 1·0, 95% CI 0·6 to 1·6; p=0·98). Intervention-related adverse events were reported by 140 (18%) of 800 participants and occurred in similar proportions in both randomisation groups. No serious adverse events were reported. Interpretation Although 17P seems to be safe and acceptable to participants, available data do not support the use of the drug to prevent preterm birth among women whose risk derives solely from HIV infection. The low risk of preterm birth in both randomisation groups warrants further investigation. Funding US National Institutes of Health and the Bill and Melinda Gates Foundation.

Antenatal corticosteroids, specifically betamethasone, administered to patients at risk for late preterm delivery have been associated with reduced rates of neonatal respiratory complications. However, whether these risks vary by delivery indication among betamethasone-exposed, late-preterm infants is not known.This study aimed to evaluate if spontaneous preterm labor or preterm prelabor rupture of membranes, compared with indicated late preterm delivery, is associated with better neonatal respiratory outcomes after accounting for betamethasone administration in the late preterm period.This was a secondary analysis of the Antenatal Late Preterm Steroids trial, a multicenter, placebo-controlled trial in which patients with singleton pregnancies at risk for delivery at 34 0/7 to 36 5/7 weeks of gestation were randomized to a single course of antenatal corticosteroids (betamethasone) or placebo. Patients were eligible if they had spontaneous preterm labor, preterm prelabor rupture of membranes, or if they were undergoing indicated late preterm delivery. The primary outcome was a composite of need for respiratory support, stillbirth, or neonatal death within 72 hours after delivery. Secondary outcomes included individual neonatal morbidities. Bivariate analyses were performed, and multivariable logistic regression models were used to control for potential confounders. Using the indicated preterm delivery group as the reference group, adjusted odds ratios and 95% confidence intervals were calculated for the outcomes by delivery indication. Subgroup analyses separately examined the treatment and placebo groups to determine the odds of the primary outcome by delivery indication.Of 2827 participants at high risk for late preterm delivery, 1427 (50.5%) received betamethasone. There were 790 (27.9%) infants born after preterm labor, 620 (21.9%) born after preterm prelabor rupture of membranes, and 1417 (50.1%) born after indicated preterm delivery. Compared with indicated preterm delivery, the odds of the primary outcome were lower among those born after preterm labor (7.3% vs 16.4%; adjusted odds ratio, 0.57; 95% confidence interval, 0.40-0.82) and among those born after preterm prelabor rupture of membranes (12.4% vs 16.4%; adjusted odds ratio, 0.49; 95% confidence interval, 0.35-0.69). Preterm labor had lower odds of all neonatal complications except feeding problems, and preterm prelabor rupture of membranes had lower odds of all neonatal complications except newborn intensive care unit admission for ≥3 days when compared with indicated preterm delivery. For the placebo group, the odds of the primary outcome were lower for the preterm labor group (8.2% vs 18.5%; adjusted odds ratio, 0.55; 95% confidence interval, 0.34-0.91) and the preterm prelabor rupture of membranes group (13.2% vs 18.5%; adjusted odds ratio, 0.46; 95% confidence interval, 0.29-0.73) than for the indicated preterm delivery group. For those exposed to betamethasone, the odds of the primary outcome remained lower for the preterm labor group (6.5% vs 14.3%; adjusted odds ratio, 0.58; 95% confidence interval, 0.34-0.99) and the preterm prelabor rupture of membranes group (11.7% vs 14.3%, adjusted odds ratio, 0.56; 95% confidence interval, 0.34-0.91) than for the indicated preterm delivery group.Compared with indicated preterm delivery, preterm labor and preterm prelabor rupture of membranes were associated with reduced odds of neonatal respiratory complications irrespective of betamethasone exposure in the late preterm period.

Background Antenatal exposure to intra-uterine inflammation results in precocious Haptoglobin (Hp) expression (switch-on status). We investigated the relationships between foetal Hp expression at birth with newborn and childhood outcomes. Methods We evaluated cord blood samples from 921 newborns of women at imminent risk for preterm delivery randomised to either placebo (n = 471, birth gestational age (GA) median [min-max]: 31 [24–41] weeks) or magnesium sulphate (n = 450, GA 31 [24–42] weeks]). Primary outcome was infant death by 1 year and/or cerebral palsy (CP) ≥ 2 years of corrected age. Adjusted odd ratios (aOR) for neonatal and childhood outcomes were calculated controlling for GA, birth weight, sex, and magnesium exposure. Findings Primary outcome occurred in 2.8% of offspring. Newborns were classified in three pre-defined categorisation groups by cord blood Hp switch status and IL-6 levels: inflammation-nonexposed (Category 1, n = 432, 47%), inflammation-exposed haptoglobinemic (Category 2, n = 449, 49%), and inflammation-exposed anhaptoglobinemic or hypohaptoglobinemic (Category 3, n = 40, 4%). Newborns, found anhaptoglobinemic or hypohaptoglobinemic (Category 3) had increased OR for intraventricular haemorrhage (IVH) and/or death (aOR: 7.0; 95% CI: 1.4–34.6, p = 0.02) and for CP and/or death (aOR: 6.27; 95% CI: 1.7–23.5, p = 0.006) compared with Category 2. Foetal ability to respond to inflammation by haptoglobinemia resulted in aOR similar to inflammation-nonexposed newborns. Hp1-2 or Hp2-2 phenotypes protected against retinopathy of prematurity (aOR = 0.66; 95% CI 0.48–0.91, p = 0.01). Interpretation Foetal ability to switch-on Hp expression in response to inflammation was associated with reduction of IVH and/or death, and CP and/or death. Foetuses unable to mount such a response had an increased risk of adverse outcomes. Trial Registration: clinicaltrials.gov Identifier: NCT00014989

The use of birthweight standards to define small for gestational age may fail to identify neonates affected by poor fetal growth as they include births associated with suboptimal fetal growth.This study aimed to compare intrauterine vs birthweight-derived standards to define newborn small for gestational age to predict neonatal morbidity and mortality.This was a secondary analysis of a multicenter observational study of 118,422 births. Live-born singleton, nonanomalous newborns born at 23 to 41 weeks of gestation were included. Those with missing gestational age estimation or without a first- or second-trimester ultrasound to confirm dating, birthweight, or neonatal outcome data were excluded. Birthweight percentile was computed using an intrauterine standard (Hadlock) and a birthweight-derived standard (Olsen). We compared the test characteristics of small for gestational age (birthweight of10th percentile) by each standard to predict a composite neonatal morbidity and mortality outcome (death before discharge, neonatal intensive care unit admission48 hours, respiratory distress syndrome, sepsis, necrotizing enterocolitis, grade 3 or 4 intraventricular hemorrhage, or seizures). Severe composite morbidity was analyzed as a secondary outcome and was defined as death, neonatal intensive care unit admission7 days, necrotizing enterocolitis, grade 3 or 4 intraventricular hemorrhage, or seizures. The areas under the curve using receiver-operating characteristic methodology and proportions of the primary outcome by small for gestational age status were compared by gestational age category at birth (34, 34 0/7 to 36 6/7, ≥37 weeks).Of 115,502 mother-newborn dyads in the parent study, 78,203 (67.7%) were included, with most exclusions occurring because of missing or inadequate dating information, multiple gestations, or delivery outside the gestational age range. The primary composite outcome occurred in 9.5% (95% confidence interval, 9.3-9.7), and the severe composite outcome occurred in 5.3% (95% confidence interval, 5.1-5.4). Small for gestational age was diagnosed by intrauterine and birthweight-derived standards in 14.8% and 7.4%, respectively (P.001). Neonates considered small for gestational age only by the intrauterine standard experienced the primary outcome more than twice as often as those considered non-small for gestational age by both standards (18.4% vs 7.9%; P.001). For the prediction of the primary outcome, small for gestational age by the intrauterine standard had higher sensitivity (29% vs 15%; P.001) but lower specificity (87% vs 93%; P.001) than by the birthweight standard. Both standards had weak performance overall, although the intrauterine standard had a higher area under the curve (0.58 vs 0.53; P.001). When subanalyzed by gestational age at birth, the difference in areas under the curve was only present among preterm deliveries 34 to 36 competed weeks. Neither standard demonstrated any discrimination for morbidity prediction among term births (area under the curve, 0.50 for both). When the prediction of severe morbidity was compared, the intrauterine still had better overall prediction than the birthweight standard (areas under the curve, 0.65 vs 0.57; P.001), although this also varied by gestational age at birth.Among nonanomalous neonates, neither intrauterine nor birthweight-derived standards for small for gestational age accurately predicted neonatal morbidity and mortality, with no discriminatory ability at term. Small for gestational age intrauterine standards performed better than birthweight standards.

Investigators have attempted to derive tools that could provide clinicians with an easily obtainable estimate of the chance of vaginal birth after cesarean delivery for those who undertake trial of labor after cesarean delivery. One tool that has been validated externally was derived from data from the Maternal-Fetal Medicine Units Cesarean Registry. However, concern has been raised that this tool includes the socially constructed variables of race and ethnicity.This study aimed to develop an accurate tool to predict vaginal birth after cesarean delivery, using data easily obtainable early in pregnancy, without the inclusion of race and ethnicity.This was a secondary analysis of the Cesarean Registry of the Maternal-Fetal Medicine Units Network. The approach to the current analysis is similar to that of the analysis in which the previous vaginal birth after cesarean delivery prediction tool was derived. Specifically, individuals were included in this analysis if they were delivered on or after 37 0/7 weeks' gestation with a live singleton cephalic fetus at the time of labor and delivery admission, had a trial of labor after cesarean delivery, and had a history of 1 previous low-transverse cesarean delivery. Information was only considered for inclusion in the model if it was ascertainable at an initial prenatal visit. Model selection and internal validation were performed using a cross-validation procedure, with the dataset randomly and equally divided into a training set and a test set. The training set was used to identify factors associated with vaginal birth after cesarean delivery and build the logistic regression predictive model using stepwise backward elimination. A final model was generated that included all variables found to be significant (P.05). The accuracy of the model to predict vaginal birth after cesarean delivery was assessed using the concordance index. The independent test set was used to estimate classification errors and validate the model that had been developed from the training set, and calibration was assessed. The final model was then applied to the overall analytical population.Of the 11,687 individuals who met the inclusion criteria for this secondary analysis, 8636 (74%) experienced vaginal birth after cesarean delivery. The backward elimination variable selection yielded a model from the training set that included maternal age, prepregnancy weight, height, indication for previous cesarean delivery, obstetrical history, and chronic hypertension. Vaginal birth after cesarean delivery was significantly more likely for women who were taller and had a previous vaginal birth, particularly if that vaginal birth had occurred after a previous cesarean delivery. Conversely, vaginal birth after cesarean delivery was significantly less likely for women whose age was older, whose weight was heavier, whose indication for previous cesarean delivery was arrest of dilation or descent, and who had a history of medication-treated chronic hypertension. The model had excellent calibration between predicted and empirical probabilities and, when applied to the overall analytical population, an area under the receiver operating characteristic curve of 0.75 (95% confidence interval, 0.74-0.77), which is similar to the area under the receiver operating characteristic curve of the previous model (0.75) that included race and ethnicity.We successfully derived an accurate model (available at https://mfmunetwork.bsc.gwu.edu/web/mfmunetwork/vaginal-birth-after-cesarean-calculator), which did not include race or ethnicity, for the estimation of the probability of vaginal birth after cesarean delivery.

Short cervix at midgestation, the presence of intraamniotic debris, and cervical funneling are risk factors for preterm birth; however, cervical length measurements and cutoffs are not well documented among pregnant patients of different gestational ages and self-reported races and ethnicities.This study aimed to describe the distribution of cervical length and frequency of funneling and debris at midgestation in nulliparous women by gestational age and race/ethnicity.This secondary analysis of screening data from a multicenter treatment trial of singleton nulliparous patients with short cervix was conducted at 14 geographically distributed, university-affiliated medical centers in the United States. Singleton nulliparous patients with no known risk factors for preterm birth were screened for trial participation and asked to undergo a transvaginal ultrasound to measure cervical length by a certified sonographer. The distribution of cervical length and the frequency of funneling and debris were assessed for each gestational age week (16-22 weeks) and stratified by self-reported race and ethnicity, which for this study were categorized as White, Black, Hispanic, and other. Patients enrolled in the randomized trial were excluded from this analysis.A total of 12,407 nulliparous patients were included in this analysis. The racial or ethnic distribution of the study participants was as follows: White, 41.6%; Black, 29.6%; Hispanic, 24.2%; and others, 4.6%. The 10th percentile cervical length for the entire cohort was 31.1 mm and, when stratified by race and ethnicity, 31.9 mm for White, 30.2 mm for Black, 31.4 mm for Hispanic, and 31.2 mm for patients of other race and ethnicity (P.001). At each gestational age, the cervical length corresponding to the tenth percentile was shorter in Black patients. The 25 mm value commonly used to define a short cervix and thought to represent the 10th percentile ranged from 1.3% to 5.4% across gestational age weeks and 1.0% to 3.8% across race and ethnicity groups. Black patients had the highest rate of funneling (2.6%), whereas Hispanic and Black patients had higher rates of intraamniotic debris than White and other patients (P.001).Black patients had shorter cervical length and higher rates of debris and funneling than White patients. The racial and ethnic disparities in sonographic midtrimester cervical findings may provide insight into the racial disparity in preterm birth rates in the United States.

BACKGROUND: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. OBJECTIVE: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals. STUDY DESIGN: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals. RESULTS: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals. CONCLUSION: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.

Maternal oxygen is often given to laboring women to improve fetal metabolic status or in an attempt to alleviate nonreassuring fetal heart rate patterns. However, the only 2 randomized trials investigating the use of maternal oxygen supplementation in laboring women do not support that such supplementation is likely to be of benefit to the fetus. And by increasing free radical activity, maternal oxygen supplementation may even be harmful. Based on a review of the available literature, we conclude that until it is studied properly in a randomized clinical trial, maternal oxygen supplementation in labor should be reserved for maternal hypoxia, and should not be considered an indicated intervention for nonreassuring fetal status.

To examine the association of elevated early pregnancy hemoglobin A1c (HbA1c) levels with adverse pregnancy outcomes in women with preexisting diabetes mellitus.Retrospective cohort study of 330 women with preexisting diabetes enrolled in a Diabetes in Pregnancy Program at an academic institution between 2003 and 2011 who had an early HbA1c determination. The frequencies of composite maternal adverse pregnancy outcomes (birth at37 weeks, preeclampsia, and medically indicated birth39 weeks), and composite fetal adverse pregnancy outcomes [shoulder dystocia, Apgar scores7 at 5 minutes, small for gestational age (SGA), large for gestational age (LGA), and stillbirth] were compared between HbA1c categories (6.5, 6.5-7.4, 7.5-8.4 and ≥ 8.5%).There was no statistically significant difference between composite adverse maternal pregnancy outcomes and composite adverse fetal pregnancy outcomes as well as other individual outcomes between different HbA1c categories. Of the vaginally delivered women in our cohort, the 37 patients with HbA1c levels of ≥ 8.5% had a significantly higher frequency of fetal shoulder dystocia than the 62 with HbA1c levels of8.5% (24.2 vs. 1.6%, P = 0.002). Neonates of patients with HbA1c ≥ 8.5% were more likely to have low five minute Apgar scores than neonates of patients with HbA1c8.5%, but this was of borderline statistical significance (7.4% vs. 0.5%, P = 0.05).In patients with preexisting diabetes mellitus, HbA1c levels of ≥ 8.5% during early pregnancy are not useful in predicting most adverse outcomes, although there may be an increased risk for shoulder dystocia.

In 2011, 1 in 3 women who gave birth in the United States did so by cesarean delivery. Cesarean birth can be lifesaving for the fetus, the mother, or both in certain cases. However, the rapid increase in cesarean birth rates from 1996 through 2011 without clear evidence of concomitant decreases in maternal or neonatal morbidity or mortality raises significant concern that cesarean delivery is overused. Variation in the rates of nulliparous, term, singleton, vertex cesarean births also indicates that clinical practice patterns affect the number of cesarean births performed. The most common indications for primary cesarean delivery include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia. Safe reduction of the rate of primary cesarean deliveries will require different approaches for each of these, as well as other, indications. For example, it may be necessary to revisit the definition of labor dystocia because recent data show that contemporary labor progresses at a rate substantially slower than what was historically taught. Additionally, improved and standardized fetal heart rate interpretation and management may have an effect. Increasing women's access to nonmedical interventions during labor, such as continuous labor and delivery support, also has been shown to reduce cesarean birth rates. External cephalic version for breech presentation and a trial of labor for women with twin gestations when the first twin is in cephalic presentation are other of several examples of interventions that can contribute to the safe lowering of the primary cesarean delivery rate.

We reviewed recent data on the prevalence, risk factors, complications, and management of trauma during pregnancy. Using the terms "trauma" and "pregnancy" along with specified mechanisms of injury, we queried the PubMed database for studies reported from Jan. 1, 1990, through May 1, 2012. Studies with the largest number of patients for a given injury type and that were population-based and/or prospective were included. Case reports and case series were used only when more robust studies were lacking. A total of 1164 abstracts were reviewed and 225 met criteria for inclusion. Domestic violence/intimate partner violence and motor vehicle crashes are the predominant causes of reported trauma during pregnancy. Management of trauma during pregnancy is dictated by its severity and should be initially geared toward maternal stabilization. Minor trauma can often be safely evaluated with simple diagnostic modalities. Pregnancy should not lead to underdiagnosis or undertreatment of trauma due to unfounded fears of fetal effects. More studies are required to elucidate the safest and most cost-effective strategies for the management of trauma in pregnancy.

We sought to describe the clinical characteristics of pregnant women with influenza-like illness during the 2009 H1N1 pandemic with the use of a standardized management algorithm. From June 2009 through March 2010, we assembled a prospective cohort of pregnant women with influenza-like illness at a single tertiary care center using a standardized algorithm. Clinical outcomes were compared between women with 2009 H1N1 virus and those without. In all, 45 women were included. Seventeen had 2009 H1N1 infection and 28 did not. Demographic characteristics were similar between groups. The median temperature upon presentation (99.7 vs 98.8°F, P = .004) was slightly higher among those with 2009 H1N1. All those with 2009 H1N1 influenza and 89% of those without were treated with oseltamivir. A total of 12 women (27%) were hospitalized. There were no endotracheal intubations or deaths. Among this cohort of pregnant women, most were treated as outpatients and had favorable maternal outcomes.

Background Studies of early-term birth after demonstrated fetal lung maturity show that respiratory and other outcomes are worse with early-term birth (370–386 weeks) even after demonstrated fetal lung maturity when compared with full-term birth (390–406 weeks). However, these studies included medically indicated births and are therefore potentially limited by confounding by the indication for delivery. Thus, the increase in adverse outcomes might be due to the indication for early-term birth rather than the early-term birth itself. Objective We examined the prevalence and risks of adverse neonatal outcomes associated with early-term birth after confirmed fetal lung maturity as compared with full-term birth in the absence of indications for early delivery. Study Design This is a secondary analysis of an observational study of births to 115,502 women in 25 hospitals in the United States from 2008 through 2011. Singleton nonanomalous births at 37–40 weeks with no identifiable indication for delivery were included; early-term births after positive fetal lung maturity testing were compared with full-term births. The primary outcome was a composite of death, ventilator for ≥2 days, continuous positive airway pressure, proven sepsis, pneumonia or meningitis, treated hypoglycemia, hyperbilirubinemia (phototherapy), and 5-minute Apgar Results In all, 48,137 births met inclusion criteria; the prevalence of fetal lung maturity testing in the absence of medical or obstetric indications for early delivery was 0.52% (n = 249). There were 180 (0.37%) early-term births after confirmed pulmonary maturity and 47,957 full-term births. Women in the former group were more likely to be non-Hispanic white, smoke, have received antenatal steroids, have induction, and have a cesarean. Risks of the composite (16.1% vs 5.4%; adjusted odds ratio, 3.2; 95% confidence interval, 2.1–4.8 from logistic regression) were more frequent with elective early-term birth. Propensity scores matching confirmed the increased primary composite in elective early-term births: adjusted odds ratios, 4.3 (95% confidence interval, 1.8–10.5) for 1:1 and 3.5 (95% confidence interval, 1.8–6.5) for 1:2 matching. Among components of the primary outcome, CPAP use and hyperbilirubinemia requiring phototherapy were significantly increased. Transient tachypnea of the newborn, neonatal intensive care unit admission, and prolonged neonatal intensive care unit stay (>2 days) were also increased with early-term birth. Conclusion Even with confirmed pulmonary maturity, early-term birth in the absence of medical or obstetric indications is associated with worse neonatal respiratory and hepatic outcomes compared with full-term birth, suggesting relative immaturity of these organ systems in early-term births.

The article was designed to estimate the effect of active and passive household cigarette smoke exposure on asthma severity and obstetric and neonatal outcomes in pregnant women with asthma.We used a secondary observational analysis of pregnant women with mild and moderate-severe asthma enrolled in a prospective observational cohort study of asthma in pregnancy and a randomized clinical trial (RCT) comparing inhaled beclomethasone and oral theophylline. A baseline questionnaire detailing smoking history and passive household smoke exposure was given to each patient. Smoking status was confirmed in the RCT using cotinine levels. Data on asthma severity and obstetric and neonatal outcomes were collected and analyzed with respect to self-reported tobacco smoke exposure. Kruskal-Wallis and Pearson chi(2) statistics were used to test for significance.A total of 2,210 women were enrolled: 1,812 in the observational study and 398 in the RCT. Four hundred and eight (18%) women reported current active smoking. Of the nonsmokers, 790 (36%) women reported passive household smoke exposure. Active smoking was associated with more total symptomatic days (P.001) and nights of sleep disturbance (P.001). Among the newborns of active smokers, there was a greater risk of small for gestational age10th percentile (P.001), and a lower mean birth weight (P.001). There were no differences in symptom exacerbation or outcome between nonsmokers with and without passive household cigarette smoke exposure.Among pregnant women with asthma, active but not passive smoking is associated with increased asthma symptoms and fetal growth abnormalities.

Cesarean delivery is indicated at any stage in the labor process in the presence of nonreassuring fetal status or when conservative measures fail in the setting of abnormal labor. In the absence of maternal or fetal indications for expedited delivery, cesarean delivery is not indicated for latent phase disorders. When to intervene for protracted labor is arguable, but slow rates of labor progress are consistent with safe vaginal delivery. Cesarean delivery in the second stage should be avoided for at least 4 hours if there is progressive fetal descent.

The purpose of this study was to determine the influence of change in infant birth weight between pregnancies on the outcome of a trial of labor for women whose first cesarean delivery was performed for dystocia.Secondary analysis of 7081 patients with 1 previous cesarean delivery and no other deliveries after 20 weeks' gestation, undergoing a trial of labor with a singleton gestation. Cases were classified as dystocia if the listed indication for the cesarean delivery in the first pregnancy was failed induction, cephalo-pelvic disproportion, failure to progress, or failed forceps or vacuum. Outcomes of the trial of labor were correlated with fetal size relative to birth weight in the initial pregnancy for those women whose initial cesarean delivery was for dystocia and those with other indications.For the cohort being studied (n = 7081), dystocia was the indication for the first cesarean delivery for 3182 (44.9%). Trial of labor resulted in vaginal delivery for 54% of patients whose first cesarean delivery was performed for dystocia, compared with 67% for those with other indications (P.01). For those whose first cesarean delivery was for dystocia, trial of labor success was correlated with birth weight differences between the pregnancies, with only 38% delivering vaginally if the trial of labor birth weight exceeded the initial pregnancy birth weight by more than 500 g. Using logistic regression and adjusting for other potential confounding factors, the odds of success decreased by 3.8% for each increase of 100 g in birth weight in the trial of labor relative to the first birth weight.For women with previous cesarean delivery for dystocia, increasing birth weight in the subsequent trial of labor relative to the first birth weight diminishes the chances of successful vaginal delivery.

Objective This study was undertaken to compare success rates of vaginal birth after cesarean (VBAC) delivery, and uterine rupture as well as maternal/perinatal outcomes between women with preterm and term pregnancies undergoing trial of labor (TOL), and to compare maternal and neonatal morbidities in those women with preterm pregnancies undergoing a TOL versus repeat cesarean delivery without labor (RCD). Study design Prospective 4-year observational study of women with a singleton gestation and a prior cesarean delivery at 19 academic centers. Clinical characteristics, maternal complications and VBAC delivery success for those with a preterm (24 0 -36 6 weeks) TOL, preterm RCD and term TOL (≥37 weeks) were analyzed. Results Among 3119 preterm pregnancies with prior cesarean delivery, 2338 (75%) underwent a TOL. 15,331 women undergoing TOL at term were also analyzed as a control group. TOL success rates for preterm and term pregnancies were similar (72.8% vs 73.3%, P = .64). Rates of uterine rupture (0.34% vs 0.74%, P = .03) and dehiscence (0.26% vs 0.67%, P = .02) were lower in preterm compared with term TOL. Thromboembolic disease, coagulopathy and transfusion were more common in women undergoing a preterm TOL than those at term. Among women undergoing a preterm TOL, rates of uterine dehiscence, coagulopathy, transfusion, and endometritis were similar to those having a preterm RCD. After controlling for gestational age at delivery and race, neonatal outcomes such as Neonatal Intensive Care Unit (NICU) admission, intraventricular hemorrhage, sepsis, and ventilatory support were similar in both groups except for a higher rate of respiratory distress syndrome in those delivered after a TOL. Conclusion The likelihood of VBAC success after TOL in preterm pregnancies is comparable to term gestations, with a lower risk of uterine rupture. Perinatal outcomes are similar with preterm TOL and RCD. TOL should be considered as an option for women undergoing preterm delivery with a history of prior cesarean delivery.

Objective The purpose of this study was to define independent risk factors for uterine atony after primary cesarean delivery, and to assess their overall association with atony in the study cohort. Study design This was a 13–university center prospective observational study. All women who underwent primary cesarean from January 1, 1999 to December 31, 2000 were eligible. Trained and certified research nurses performed systematic data abstraction. The definition of atony required both the clinical diagnosis and the use of methergine or a prostaglandin preparation. Risk factors for uterine atony were assessed in univariable and multivariable logistic regression analyses, and these analyses then used to inform an assessment of the association of the various risk factors with the occurrence of uterine atony in the overall cohort. Results Twenty-three thousand, three hundred and ninety pregnancies were analyzed. Uterine atony occurred in 1416 women (6%). Several variables were independently associated with atony in a multivariable model, including multiple gestation (odds ratio [OR] 2.40, 95% CI 1.95-2.93), maternal Hispanic race (2.21, 1.90-2.57), induced or augmented labor for >18 hours (2.23, 1.92-2.60), infant birth weight >4500 g (2.05, 1.53-2.69), and clinically diagnosed chorioamnionitis (1.80, 1.55-2.09). However, because the various risk factors were not very powerful, approximately half of the cases of atony were associated with the 2/3 of women lacking a given risk factor or combination of risk factors. Conclusion Although certain risk factors and uterine atony were clearly associated, the associations are of limited practical clinical use.

This study was undertaken to investigate the association among plurality (number of fetuses per pregnancy), abruptio placenta, and perinatal mortality.A retrospective cohort study on 15,051,872 singletons, 413,619 twins, and 22,585 triplets delivered in the United States between 1995 and 1998 was conducted. We compared the occurrence of perinatal death between pregnancies complicated by abruptio placenta and those without with the use of adjusted odds ratios. The generalized estimating equations framework was applied to adjust for intracluster correlations among multiples.Placental abruption occurred among 93,968 singletons (6.2 per 1000), 5051 twin (12.2 per 1000), and 353 triplet (15.6 per 1000) gestations ( P for trend.0001). Placental abruption was associated with significant risk of mortality irrespective of the plurality subtype. Perinatal mortality was greatest among singletons (adjusted odds ratio [95% CI]=14.3[13.2-15.4]), followed by twins (4.4[3.9-4.9]) and least among triplets (3.0[2.0-4.6]) ( P for trend.0001).As plurality increases from 1 to 3, the risk of placental abruption rises, whereas the risk of abruptio-associated perinatal mortality declines.

Objective The purposes of this study were to assess survival among triplets who are born to teen mothers and to determine whether fetal number influences the mortality rates of the offspring of teen mothers when compared with the offspring of older women. Study design A retrospective cohort study of 354 triplet births to teenage mothers and 6858 to young mature mothers (20-29 years) who were delivered from 1995 through 1998. We compared the occurrence of stillbirth and neonatal and infant mortality rates between the 2 categories by means of the generalized estimating equation. Similar analyses were conducted for singleton pregnancies and twin pregnancies. Results Triplets of teenage mothers experienced a higher level of stillbirth (odds ratio, 3.24; 95% CI, 1.44-7.24), neonatal mortality (odds ratio, 2.00; 95% CI, 1.11-3.61), and infant death (odds ratio, 1.66; 95% CI, 1.01-2.87). Moreover, as the plurality increased from singleton infant to triplet, the offspring of teenagers fared progressively worse (P Conclusion This study confirms the association between teenage motherhood and feto-infant death and indicates that this mortality relationship varies in a dose-dependent fashion.

The purpose of this study was to evaluate the relationship between chorioamnionitis and its duration to adverse maternal, fetal, and neonatal outcomes.This was a 13-university center, prospective observational study. All women at term carrying a singleton gestation who underwent primary cesarean from January 1, 1999 to December 31, 2000 were eligible. Data abstraction was systematic and performed by trained research nurses. Selected adverse outcomes were compared between pregnancies with, and without, clinically diagnosed chorioamnionitis using relative risks (RRs) and 95% CIs. The duration of chorioamnionitis was stratified into 5 intervals (or=3 h,3-6 h,6-9 h,9-12 h, and12 h), and respective outcomes compared by Mantel-Haenszel test for trend. Additionally, regression analysis was used to compute odds ratios (ORs) and 95% CIs for chorioamnionitis duration length as a continuous explanatory variable.16,650 pregnancies were analyzed, 1965 (12%) with chorioamnionitis, which was associated with significantly increased risks of maternal blood transfusion, uterine atony, septic pelvic thrombophlebitis, and pelvic abscess (RR 2.3-3.7), as well as 5-minute Apgaror=3, neonatal sepsis, and seizures (RR 2.1-2.8). By test of trend, only uterine atony (P.01), maternal blood transfusion (P=.03), maternal admission to intensive care unit (P=.02), and 5-minute Apgaror=3 (P.01) were associated with duration of chorioamnionitis. By logistic analysis, only uterine atony (OR for each hour of chorioamnionitis 1.03, 95% CI 1.00-1.06), 5-minute Apgaror=3 (OR 1.09, 95% CI 1.00-1.16), and neonatal mechanical ventilation within 24 hours of birth (OR 1.07, 95% CI 1.01-1.12) were significantly associated with chorioamnionitis duration.Chorioamnionitis was associated with increased rates of morbidity after cesarean at term. The duration of chorioamnionitis, however, was not related to most measures of adverse maternal or fetal-neonatal outcome.

Each year about 2 million babies are born to HIV-1- infected women. Despite widespread knowledge of proven methods to prevent mother-to-child transmission (MTCT) of the virus most infants at risk of contracting the infection from their mothers receive no prophylactic intervention. This inaction leads to the infection and ultimate death of about 800 000 children per year. It has been known since 1994 that MTCT is largely preventable and interventions appropriate for use in the developing world have been available since 1999. Singledose intrapartum and neonatal nevirapine—the simplest and perhaps most effective of the short-course antiretroviral regimens studied—has been available free of charge from the manufacturer since 2000. Nevertheless few women have access to MTCT-prevention services. In the more than 3 years since its inception the donation programme has shipped only 189 000 courses of the drug a tiny fraction (

The National Institute of Child Health and Human Development (NICHD) created the NICHD Maternal Fetal Medicine Units Network in 1986 to conduct randomized trials and observational studies in perinatal medicine to improve adverse pregnancy and infant outcomes. From 1986 to 2002, the Network has started 16 randomized trials. Five of the trials are described, with particular attention given to difficult issues that arose, such as feasibility, sample size estimation, randomization in very high risk pregnancies, changing clinical practice, importance of the study question to the investigators, and lack of recruitment. Changes that the Network group made to their organization and methodology as a result of these issues are described, together with their application to some of the other trials proposed and conducted by the group.

The potential cost-effectiveness of antenatal nutrition interventions to improve pregnancy outcomes in the developing world has not undergone formal evaluation. Furthermore, the effectiveness of antenatal care in improving maternal or fetal and neonatal health has been questioned. However, reasonably compelling evidence from randomized trials shows that nutrition interventions can prevent both infant (iodine supplementation) and maternal (vitamin A and beta-carotene supplementation) deaths, and informal analysis suggests that the cost-effectiveness of nutrition interventions would be comparable and, in some cases, markedly superior to several standard antenatal interventions. Future efforts to establish the cost-effectiveness of nutrition interventions in developing countries will depend on conducting large, pragmatic clinical trials that use region- and resource-appropriate interventions with mortality or valid, incontrovertibly severe morbidity endpoints. If such trials establish effectiveness, credible cost-effectiveness analyses can then be performed.

In this study, we assessed the temporal trends and relative and attributable perinatal risks of maternal obesity over a 20-year period.We conducted a retrospective cohort study between 1980 and 1999 by using a computerized perinatal database of all women who received prenatal care and delivered their infants within a regional health care system. The main outcome measures were as follows: (1) annual mean body weight and the percentage of women classified as obese at the first prenatal visit (primary definitionor = 200 lb; secondary definitionsor = 250 lb,or = 300 lb, body mass index29 kg/m(2)); and (2) relative and attributable risks of obesity for selected maternal and perinatal morbidities in successive 5-year periods.From 1980 to 1999, the mean maternal weight of women at the first prenatal visit increased 20% (144-172 lb), as did the percentage of womenor = 200 lb (7.3-24.4), the percentageor = 250 lb (1.9-10.7), the percentageor = 300 lb (0.5-4.9), and the percentage with a body mass index29 kg/m(2) (16.3-36.4), P.01 for all. Controlling for maternal age, race, and smoking status, obese women were at increased risk at each period for cesarean delivery (range of adjusted relative risk, 1.5-1.8), gestational diabetes (range, 1.8-2.9), and large (90th percentile) for gestational age infants (range, 1.8-2.2). From the earliest 5-year period (1980-1984) to the most recent (1995-1999), the percentage of obesity-attributable cesarean deliveries more than tripled from 3.9 to 11.6. Similar percentage increases were observed for the obesity-attributable risks for gestational diabetes (12.8-29.6) and large for gestational age infants (6.5-19.1). Trends for secondary obesity definitions were similar, although the magnitude of the increased attributable risks was smaller.Efforts to reduce the frequency of certain perinatal morbidities will be constrained unless effective measures to prevent, or limit the risks of, maternal obesity are developed and implemented.

Although magnesium sulfate is widely used as a tocolytic agent in the hope of preventing spontaneous preterm birth, there is a paucity of data from large well-designed randomized, clinical studies demonstrating the efficacy of magnesium sulfate therapy. Given the potential for untoward side effects and the inherent risks of magnesium sulfate therapy, a thorough understanding of the potential risks and benefits of this agent is needed. To accomplish this understanding we have provided a detailed, review the history, pharmacology, physiology, maternal/fetal side effects, and tocolytic efficacy of magnesium sulfate.