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.

Predicting cesarean delivery among gravidas with morbid obesity-a machine learning approach.

BACKGROUND: Women with obesity have higher rates of complications following cesarean delivery, such as wound infection and endometritis, with risks being the highest if a cesarean delivery is performed after labor. Previous efforts at predicting whether a patient's labor course would ultimately result in cesarean delivery have been intermediate with area under the curve in the 0.75 to 78 range. OBJECTIVE: This study aimed to assess whether machine learning algorithms would outperform traditional modeling in developing a cesarean delivery prediction model among gravidas with morbid obesity (body mass index of ≥40 kg/m2) to determine whether a primary cesarean delivery may be beneficial. STUDY DESIGN: This was a secondary analysis of a retrospective cohort of 1298 patients with morbid obesity presenting for vaginal delivery at ≥37 weeks of gestation between 2011 and 2016 at a single institution. Data available at the time of admission and delivery were modeled using logistic regression, decision tree, random forest, and support vector modeling with evaluation of area under the curve, accuracy, sensitivity, and specificity. RESULTS: Logistic regression demonstrated an area under the curve of 0.816 (95% confidence interval, 0.810-0.817), which was superior to machine learning models when evaluating data at the time of delivery (demographic data, initial cervical examinations, comorbidities, and obstetrical interventions) (P<.001). However, there was no significant difference between most machine learning models and logistic regression area under the curve of 0.799 (95% confidence interval, 0.795-0.804) when evaluating parameters available at the time of admission (demographic data, initial cervical examinations, and comorbidities). Race was noted to be a significant predictor in both models (P<.001). CONCLUSION: Machine learning and traditional modeling techniques are likely equivalent concerning cesarean delivery prediction in this population. The models developed showed good discrimination and may be used to guide clinical decision-making concerning the optimal mode of delivery.

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.

Breastfeeding initiation and duration among people with mild chronic hypertension: a secondary analysis of the Chronic Hypertension and Pregnancy trial.

BACKGROUND: Increased duration of breastfeeding improves maternal cardiovascular health and may be especially beneficial in high-risk populations, such as those with chronic hypertension. Others have shown that individuals with hypertension are less likely to breastfeed, and there has been limited research aimed at supporting breastfeeding goals in this population. The impact of perinatal blood pressure control on breastfeeding outcomes among people with chronic hypertension is unknown. OBJECTIVE: This study aimed to evaluate whether breastfeeding initiation and short-term duration assessed at the postpartum clinic visit differed according to perinatal blood pressure treatment strategy (targeting blood pressure <140/90 mm Hg vs reserving antihypertensive treatment for blood pressure ≥160/105 mm Hg). STUDY DESIGN: We performed a secondary analysis of the Chronic Hypertension and Pregnancy trial. This was an open-label, multicenter, randomized trial where pregnant participants with mild chronic hypertension were randomized to receive antihypertensive medications with goal blood pressure <140/90 mm Hg (active treatment) or deferred treatment until blood pressure ≥160/105 mm Hg (control). The primary outcome was initiation and duration of breastfeeding, assessed at the postpartum clinic visit. We performed bivariate analyses and log-binomial and cumulative logit regression models, adjusting models for variables that were unbalanced in bivariate analyses. We performed additional analyses to explore the relationship between breastfeeding duration and blood pressure measurements at the postpartum visit. RESULTS: Of the 2408 participants from the Chronic Hypertension and Pregnancy trial, 1444 (60%) attended the postpartum study visit and provided breastfeeding information. Participants in the active treatment group had different body mass index class distribution and earlier gestational age at enrollment, and (by design) were more often discharged on antihypertensives. Breastfeeding outcomes did not differ significantly by treatment group. In the active and control treatment groups, 563 (77.5%) and 561 (78.1%) initiated breastfeeding, and mean durations of breastfeeding were 6.5±2.3 and 6.3±2.1 weeks, respectively. The probability of ever breastfeeding (adjusted relative risk, 0.99; 95% confidence interval, 0.93-1.05), current breastfeeding at postpartum visit (adjusted relative risk, 1.01; 95% confidence interval, 0.94-1.10), and weeks of breastfeeding (adjusted odds ratio, 0.87; 95% confidence interval, 0.68-1.12) did not differ by treatment group. Increased duration (≥2 vs <2 weeks) of breastfeeding was associated with slightly lower blood pressure measurements at the postpartum visit, but these differences were not significant in adjusted models. CONCLUSION: In a secondary analysis of the cohort of Chronic Hypertension and Pregnancy trial participants who attended the postpartum study visit and provided breastfeeding information (60% of original trial participants), breastfeeding outcomes did not differ significantly by treatment group. This suggests that maintaining goal blood pressure <140/90 mm Hg throughout the perinatal period is associated with neither harm nor benefit for short-term breastfeeding goals. Further study is needed to understand long-term breastfeeding outcomes among individuals with chronic hypertension and how to support this population in achieving their breastfeeding goals.

Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials.

BACKGROUND: Induction of labour is one of the most common obstetric interventions globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We aimed to compare the effectiveness and safety profiles of these two induction methods. METHODS: We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for cervical ripening before labour induction. We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and PubMed. Further trials done before March 19, 2019, were identified through a recent Cochrane review. Data relating to the combined use of the two methods were not included, only data from women with a viable, singleton pregnancy were analysed, and no exclusion was made based on parity or membrane status. We contacted authors of individuals trials and participant-level data were harmonised and recoded according to predefined definitions of variables. Risk of bias was assessed with the ROB2 tool. The primary outcomes were caesarean delivery, indication for caesarean delivery, a composite adverse perinatal outcome, and a composite adverse maternal outcome. We followed the intention-to-treat principle for the main analysis. The primary meta-analysis used two-stage random-effects models and the sensitivity analysis used one-stage mixed models. All models were adjusted for maternal age and parity. This meta-analysis is registered with PROSPERO (CRD42020179924). FINDINGS: Individual participant data were available from 12 studies with a total of 5460 participants. Balloon catheters, compared with vaginal prostaglandins, did not lead to a significantly different rate of caesarean delivery (12 trials, 5414 women; crude incidence 27·0%; adjusted OR [aOR] 1·09, 95% CI 0·95-1·24; I2=0%), caesarean delivery for failure to progress (11 trials, 4601 women; aOR 1·20, 95% CI 0·91-1·58; I2=39%), or caesarean delivery for fetal distress (10 trials, 4441 women; aOR 0·86, 95% CI 0·71-1·04; I2=0%). The composite adverse perinatal outcome was lower in women who were allocated to balloon catheters than in those allocated to vaginal prostaglandins (ten trials, 4452 neonates, crude incidence 13·6%; aOR 0·80, 95% CI 0·70-0·92; I2=0%). There was no significant difference in the composite adverse maternal outcome (ten trials, 4326 women, crude incidence 22·7%; aOR 1·02, 95% CI 0·89-1·18; I2=0%). INTERPRETATION: In induction of labour, balloon catheters and vaginal prostaglandins have comparable caesarean delivery rates and maternal safety profiles, but balloon catheters lead to fewer adverse perinatal events. FUNDING: Australian National Health and Medical Research Council and Monash Health Emerging Researcher Fellowship.

Immediate weight loss before ovarian stimulation with intrauterine insemination is associated with a lower risk of preeclampsia in women with obesity and unexplained infertility.

Objective: To determine whether successful weight loss before ovarian stimulation with intrauterine insemination (OS-IUI) affects the risk of future pregnancy complications among women with obesity and unexplained infertility after fertility treatment. Design: Secondary analysis of the randomized controlled clinical trial Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility (FIT-PLESE). Setting: Multiple academic health centers in the United States. Patients: Three hundred seventy-nine women with obesity and unexplained infertility who underwent standard infertility treatment after a lifestyle intervention. Interventions: The FIT-PLESE trial evaluated whether prepregnancy lifestyle interventions (diet with weight loss medication and exercise vs. exercise alone) before OS-IUI improved the live birth rate among women with obesity and unexplained infertility. Although the primary outcome of FIT-PLESE was live birth rate, we compared the demographics and subsequent pregnancy complications of women who successfully lost some weight with those of women who did not lose any during the interventions. Main Outcome Measures: Obstetric complications by groups were compared using χ2 and Fisher's exact tests, and continuous variables were compared using Student's t-tests. Logistic regression was used to assess the odds of preeclampsia after adjustment for the randomized treatment arm in FIT-PLESE. Results: There was a nonsignificant trend toward a lower risk of intrauterine growth restriction (4% vs. 16%, P = .124) and preterm delivery (6% vs. 15%, P = .343) among patients who lost at least some weight. The risk of preeclampsia was significantly lower (6% vs.35%, P = .002) in the weight loss group (odds ratio, 0.09; 95% confidence interval, 0.016-0.505; P = .006) after adjustment for treatment assignment. Conclusions: Among women with obesity and unexplained infertility who had live births after fertility treatment, prepregnancy weight loss due to lifestyle interventions before OS-IUI was associated with a lower risk of preeclampsia.

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial.

BACKGROUND: Women with obesity are at increased risk of complications during and after labor and delivery, including puerperal infection and cesarean delivery. As labor induction has become increasingly common, it is crucial to find ways to decrease complication rates in this high-risk population. OBJECTIVE: This study aimed to explore the effect of prophylactic antibiotics during labor induction of nulliparous women with obesity on the rates of cesarean delivery and puerperal infection and to estimate the parameters needed to calculate the sample size for a larger, multicenter trial. STUDY DESIGN: In this randomized, placebo-controlled pilot trial, nulliparous patients with a body mass index of ≥30 kg/m2 were randomized to either prophylactic antibiotics (500 mg azithromycin for 1 dose and 2 g cefazolin every 8 hours for up to 3 doses) or placebo, administered starting at the beginning of labor induction. The exclusion criteria were known fetal anomaly, fetal demise, multifetal gestation, ruptured membranes >12 hours, infection requiring antibiotics at the start of labor induction, and/or allergy to azithromycin or beta-lactam antibiotics. The co-primary outcomes were rates of puerperal infection (composite of chorioamnionitis, endometritis, and/or cesarean delivery wound infection) and cesarean delivery. Participants were followed up for 30 days after delivery, and maternal and neonatal demographic and outcome data were collected. Proportions and 95% confidence limits were calculated for each of these outcomes. RESULTS: From January 2019 to May 2021, 101 patients were randomized in the class III stratum (1 patient who was randomized ultimately did not undergo labor induction). From February 2020 to May 2021, 38 and 47 patients were randomized to class I and II strata, respectively (to assess the effect of obesity class on the outcomes expected to be influenced by antibiotic prophylaxis). In the antibiotics and placebo groups, the rates of cesarean delivery were 29.0% (95% confidence interval, 19.8-38.3) and 39.8% (95% confidence interval, 29.8-49.7), respectively, and puerperal infection occurred in 8.6% (95% confidence interval, 2.9-14.3) and 9.7% (95% confidence interval, 3.7-15.7), respectively. In the subgroup with class III obesity, in the antibiotics and placebo groups, the rates of cesarean delivery were 33.3% (95% confidence interval, 20.4-47.9) and 46.0% (95% confidence interval, 32.2-59.8), respectively, and puerperal infection occurred in 7.8% (95% confidence interval, 0.5-15.2) and 10.0% (95% confidence interval, 1.7-18.3), respectively. Note that this pilot study was not powered to detect differences of this magnitude but rather to estimate parameters. CONCLUSION: The administration of prophylactic antibiotics during labor induction of nulliparous patients with obesity resulted in a 27% lower cesarean delivery rate overall and a 28% lower rate in patients with class III obesity. A larger trial is warranted to evaluate these differences.

Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia.

BACKGROUND: The ability to diagnose preeclampsia clinically is suboptimal. Our objective was to validate a novel multianalyte assay and characterize its performance, when intended for use as an aid to rule-out preeclampsia. METHODS: Prospective, multicenter cohort study of pregnant individuals presenting between 280/7 and 366/7 weeks' with preeclampsia-associated signs and symptoms. Individuals not diagnosed with preeclampsia after baseline evaluation were enrolled in the study cohort, with those who later developed preeclampsia, classified as cases and compared with a negative control group who did not develop preeclampsia. Individuals with assay values at time of enrollment ≥0.0325, determined using a previously developed algorithm, considered at risk. The primary analysis was the time to develop preeclampsia assessed using a multivariate Cox regression model. RESULTS: One thousand thirty-six pregnant individuals were enrolled in the study cohort with an incidence of preeclampsia of 30.3% (27.6%-33.2%). The time to develop preeclampsia was shorter for those with an at-risk compared with negative assay result (log-rank P<0.0001; adjusted hazard ratio of 4.81 [3.69-6.27, P<0.0001]). The performance metrics for the assay to rule-out preeclampsia within 7 days of enrollment showed a sensitivity 76.4% (67.5%-83.5%), negative predictive value 95.0% (92.8%-96.6%), and negative likelihood ratio 0.46 (0.32-0.65). Assay performance improved if delivery occurred <37 weeks and for individuals enrolled between 28 and 35 weeks. CONCLUSIONS: We confirmed that a novel multianalyte assay was associated with the time to develop preeclampsia and has a moderate sensitivity and negative likelihood ratio but high negative predictive value when assessed as an aid to rule out preeclampsia within 7 days of enrollment. REGISTRATION: The study was registered on Clinicaltrials.gov (Identifier NCT02780414).

Treatment for Mild Chronic Hypertension during Pregnancy.

BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth. RESULTS: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99). CONCLUSIONS: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).

Vaginal-perianal or vaginal-perineal compared with vaginal-rectal culture-based screening for Group B Streptococci (GBS) colonization during the third trimester of pregnancy: a systematic review and meta-analysis.

BACKGROUND: Screening for maternal anogenital Group B streptococci (GBS) colonization in pregnancy with initiation of intravenous intrapartum antibiotic prophylaxis as indicated has led to a significant reduction in the incidence of neonatal GBS infection. This study aims to evaluate the agreement between vaginal-perianal or vaginal-perineal culture and the more typically used vaginal-rectal culture for screening for maternal anogenital GBS colonization in the third trimester of pregnancy. METHODS: Eligible English-language studies published until January 2020 were retrieved from Scopus, Web of Science, PubMed, Embase, and ClinicalTrials.gov databases. Studies were compiled that assessed for GBS colonization utilizing vaginal-perianal or vaginal-perineal culture and vaginal-rectal culture during the third trimester of pregnancy. Nonoriginal research articles and studies that did not assess pregnant patients, did not use culture-based screening, or did not compare vaginal-perianal or vaginal-perineal culture with vaginal-rectal culture were excluded. The search identified 559 articles with three prospective cohort studies that met inclusion criteria, including 643 participants. Quality was assessed using the Newcastle-Ottawa Scale, and risk of bias was assessed using the Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool. Patient characteristics and associated pain with specimen collection were abstracted. Meta-analyses of both the raw agreement and the Cohen's kappa statistic were performed. RESULTS: Within the three included studies, the range of GBS detection was 17.6-34.0%, consistent with the anticipated prevalence of GBS colonization reported in earlier publications. For both raw agreement and Cohen's kappa coefficient, the test for heterogeneity was not significant, indicating low heterogeneity among studies. The pooled estimate of the raw agreement was 0.97 (95%CI 0.95-0.98) and of the Cohen's kappa coefficient was 0.91 (95% CI: 0.87-0.95), indicating (according to the Landis and Koch criteria) an "almost perfect" agreement between the compared clinical tests. In the two studies that assessed procedure-related patient discomfort, vaginal-rectal swabbing caused more discomfort. CONCLUSION: Use of vaginal-perineal culture for assessment of maternal GBS colonization is comparable to the more typically utilized vaginal-rectal culture and is associated with less discomfort.

The association of skin incision placement during cesarean delivery with wound complications in obese women: a systematic review and meta-analysis.

OBJECTIVE: To determine the risk of wound complications by skin incision type in obese women undergoing cesarean delivery.Data sources: Electronic databases (MEDLINE, Scopus, and Ovid) were searched from their inception through August 2018.Methods of study selection: We included all randomized controlled trials and cohort studies reporting the placement of skin incision during cesarean section in obese women, defined as those with BMI ≥30 kg/m2. Studies were included if they compared one placement of skin incision with a different one as comparison group. The primary outcome was incidence of wound complications, while secondary outcomes included wound infection, hematoma, seroma, postpartum hemorrhage, and endometritis. Demographics and outcomes for each individual study identified were reported as part of the review. Meta-analysis was performed using the random effects model of DerSimonian and Laird, to produce summary treatment effects in terms of mean difference (MD) or relative risk (RR) with 95% confidence interval (CI). Sub-group analyses (vertical versus Pfannenstiel) were also reported.Tabulation, integration and results: Seventeen studies (including 3 RCTs; 8960 participants among the 15 non-overlapping studies) were included in the systematic review. Vertical incisions were associated with a relative risk of 2.07 (95% CI1.61-2.67) for wound complications compared to transverse incisions, however significant possible confounders were present. Studies were mildly-moderately heterogeneous (I2 44.81%, 95% CI 0.00-71.85%) with varying definitions of obesity and wound complications. High transverse incisions (3 studies, 218 participants) trend toward a lower risk of wound complications compared to low transverse incisions (RR 0.338, 95% CI 0.114-1.004). CONCLUSIONS: Vertical incisions may be associated with an increased risk for wound complications compared to transverse incisions for cesarean delivery in obese women. Randomized controlled trials are needed to evaluate optimal cesarean skin incisions for these women.

Clinical effectiveness of adding azithromycin to antimicrobial prophylaxis for cesarean delivery.

BACKGROUND: A recent large clinical trial demonstrated an approximately 50% decrease in the rate of postoperative infection in women who were laboring and/or had rupture of membranes for >4 hours and who received azithromycin in addition to standard preoperative antibiotic prophylaxis at the time of cesarean delivery. Given these results, our institution made a policy change in May 2017 to add azithromycin to standard preoperative prophylaxis for all cesarean deliveries. OBJECTIVE: This study aimed to evaluate the clinical effectiveness of adding azithromycin to preoperative antibiotic prophylaxis for cesarean delivery. STUDY DESIGN: We conducted a before-and-after cohort study of women delivered via cesarean delivery at our institution. The preimplementation group included women who delivered from March 1, 2016, to February 28, 2017, (before an institutional practice change of adding azithromycin to standard preoperative prophylaxis), and the postimplementation group included women who delivered from September 1, 2017, to August 31, 2018 (allowing a 6-month period for uptake of the practice change). The primary outcome was a composite of postoperative infections (endometritis, wound infection, other maternal infections). Unadjusted and adjusted risk ratios and 95% confidence intervals were estimated using a modified Poisson regression model. RESULTS: In the preimplementation (n=1171) and postimplementation (n=1168) groups, the incidence rates of the composite outcomes were 4.7% and 5.3%, respectively (P=.49). Both unadjusted (relative risk, 1.13; 95% confidence interval, 0.78-1.62) and adjusted (adjusted relative risk, 1.06; 95% confidence interval, 0.74-1.52) comparisons were not significantly different. In addition, results were statistically nonsignificant, but in the direction of lower rates of infection, in the after cohort for women in labor and/or with rupture of membranes for ≥4 hours (relative risk, 0.88 [95% confidence interval, 0.56-1.39]; adjusted relative risk, 0.82 [95% confidence interval, 0.52-1.30]) and for women with clinical chorioamnionitis (relative risk, 0.37 [95% confidence interval, 0.08-1.67]; data too sparse for adjusted analysis). In the subgroup of women who were not in labor, the after cohort had a statistically nonsignificant increased risk of the composite outcome in both unadjusted (relative risk, 1.53; 95% confidence interval, 0.86-2.72) and adjusted (adjusted relative risk, 1.48; 95% confidence interval, 0.83-2.65]) comparisons. CONCLUSION: In clinical practice, the addition of azithromycin to standard preoperative antibiotic prophylaxis for cesarean delivery may have an effect size smaller than seen in the large clinical trial prompting this practice change. Extrapolation of this regimen to women not in labor may be ineffective.

Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial.

OBJECTIVE: The aim of study is to compare, in a pilot study, combined dinoprostone vaginal insert and Foley catheter (DVI + Foley) with Foley alone (Foley) for cervical ripening and labor induction at term. STUDY DESIGN: In this open-label pilot randomized controlled trial, women not in labor, with intact membranes, no prior uterine incision, an unfavorable cervix, gestational age ≥37 weeks, and a live, nonanomalous singleton fetus in cephalic presentation were randomly assigned, stratified by parity, to DVI + Foley or Foley. Oxytocin was used in both groups after cervical ripening. Primary outcome was time to vaginal delivery. RESULTS: From April 2017 to January 2018, 100 women were randomized. Median (25-75th percentile) time to vaginal delivery for nulliparous women was 21.2 (16.6-38.0) hours with DVI + Foley (n = 26) compared with 31.3 (23.3-46.9) hours with Foley (n = 24) (Wilcoxon p = 0.05). Median time to vaginal delivery for parous women was 17.1 (13.6-21.9) hours with DVI + Foley (n = 25) compared with 14.8 (12.7-19.5) hours with Foley (n = 25) (Wilcoxon p = 0.21). Results were also analyzed to consider the competing risk of cesarean using cumulative incidence functions. CONCLUSION: Compared with Foley alone, combined use of the dinoprostone vaginal insert and Foley for cervical ripening may shorten time to vaginal delivery for nulliparous but not parous women.

Patient Satisfaction with Outpatient Cervical Ripening in Parous Women.

OBJECTIVE: This study aimed to assess whether patient satisfaction differs between women beginning cervical ripening in the outpatient versus inpatient setting. STUDY DESIGN: We performed a planned secondary analysis evaluating patient satisfaction randomized to outpatient versus inpatient cervical ripening. In the original randomized controlled trial, low-risk parous women ≥39 weeks who required cervical ripening for induction and had reassuring fetal heart rate monitoring were included and randomized to inpatient versus outpatient ripening with a transcervical Foley's catheter. All women were then admitted to the labor ward on the following day. Patient satisfaction was evaluated using three separate surveys. The first two surveys, Six Simple Questions and Lady-X, were previously validated. The third survey used visual analog scales to assess overall pain experienced during Foley's placement, overall pain experienced during labor, how likely they would be to choose the same type of care for their next pregnancy, and how likely they would be to recommend their method of cervical ripening to friends/family. RESULTS: From May 2016 to October 2017, 129 women were randomized (outpatient, 65; inpatient, 64). Based on survey results, there was no difference in satisfaction between outpatient and inpatient cervical ripening with transcervical Foley's catheterization, with high satisfaction in both groups. Patients in both the outpatient and inpatient groups would choose the same type of care for their next pregnancy (on a scale of 1-7, median (25th-75th percentile): 7 [7-7] vs. 7 [6-7], respectively, p = 0.75) and would be very likely to recommend their method of induction to a friend or family member (on a scale of 0-100, 99 [80-100] vs. 99 [65-100], respectively, p = 0.60). CONCLUSION: Parous women's satisfaction does not differ between inpatient and outpatient cervical ripening with transcervical Foley's catheterization. KEY POINTS: · Outpatient cervical ripening may allow providers to incorporate the benefits of electively inducing women as well as decrease the time spent in the labor and delivery unit.. · Parous women's satisfaction does not differ between inpatient and outpatient cervical ripening with transcervical Foley.. · Additional prospective evaluation is warranted to further characterize patient preferences in relation to the location of cervical ripening..

Impact of a Policy to Deliver at 39 Weeks for the Indication of Class III Obesity.

OBJECTIVE: The aim of this study was to evaluate the effect of a policy to deliver at 39 weeks for class III obesity. METHODS: This was a retrospective cohort study of women with class III obesity delivering at ≥ 37 weeks before (May 2012 to April 2014) and after the policy (September 2014 to August 2016). The primary outcome was the cesarean rate. Secondary outcomes included maternal morbidities and a neonatal morbidity composite. Modified Poisson regression was used to adjust for demographic differences between groups. RESULTS: The study included a total of 1,210 patients, 580 before the policy and 630 after the policy. Before and after the policy, cesarean rates were similar (41.6% vs. 47.1%; risk ratio [RR]: 1.13 [95% CI: 1.00-1.29]; adjusted RR [aRR]: 1.03 [95% CI: 0.92-1.14]). In adjusted comparisons of women undergoing labor induction, parous women had lower cesarean rates (aRR: 0.62; 95% CI: 0.41-0.94) but nulliparous women had higher cesarean rates (aRR: 1.32; 95% CI: 1.04-1.68) after the policy (P for interaction = 0.01). Rates of chorioamnionitis, endometritis, and cesarean wound infection were not different between groups. Composite neonatal morbidity was not different between pre- and postpolicy groups. CONCLUSIONS: A policy of delivery at 39 weeks for class III obesity did not affect overall cesarean rate or rates of maternal or neonatal morbidity. Further investigation should evaluate subsets of women who may have a higher cesarean rate with this policy.

Midtrimester microbial DNA variations in maternal serum of women who experience spontaneous preterm birth.

Objectives: To evaluate if midtrimester maternal serum contains microbial DNA and whether it differs between women with spontaneous preterm birth (SPTB) and those delivering at term.Study design: In this retrospective case-control study, we identified 20 healthy nulliparas with SPTB at 24-33 weeks of a nonanomalous singleton in 2014. Each case was matched by race/ethnicity to a control delivering at 39-40 weeks. Serum samples, collected at 15-20 weeks and stored at -80 C, were thawed and DNA extracted. PCR with primers targeting the 16S rDNA V4 region were used to prepare an amplicon library, sequenced using Illumina MiSeq, and analyzed using quantitative insight into microbial ecology (QIIME). Taxonomy was assigned using Ribosomal Database program (RDP) Classifier (threshold 0.8) against a modified Greengenes database. Differences in number of observed species, microbial alpha-diversity and beta-diversity, and taxa level analyses were undertaken.Results: All 40 samples were included. Women with SPTB had more unique observed species (p = .046) and higher mean alpha-diversity by Shannon index (but not Chao1 or Simpson) (p = .024). Microbial composition was different between groups by Bray-Curtis clustering (p = .03) but not by weighted (p = .13) or unweighted Unifrac (p = .11). Numerous taxa in the Firmicutes, Proteobacteria, and Actinobacteria phyla differed between groups (p < .05).Conclusions: SPTB is associated with distinct microbial DNA changes detected in midtrimester maternal serum.

A Case of Maternal Sepsis and Fetal Demise Associated with Streptococcus pseudoporcinus.

Streptococcus pseudoporcinus has recently been described in relation to its colonization of the female genitourinary tract. Since prior reports have linked S. pseudoporcinus only with minor morbidities, the organism previously has not been considered to be a cause of serious puerperal infections. A 41-year-old gravida 2, para 1-0-0-1 presented with abdominal pain and intrauterine fetal demise. A beta hemolytic Streptococcus was isolated from her placenta, endometrium, urine, and two blood culture sets. The isolate was a Streptococcus pseudoporcinus, which colonizes the female genital tract and can resemble Streptococcus agalactiae. This case demonstrates that S. pseudoporcinus is a potential cause of severe maternal and fetal morbidity and mortality.

Prophylaxis Against Early-onset Group B Streptococcus Infections in Pregnant Women Who Are Allergic to Penicillin.

Group B Streptococcus (GBS) infection remains a significant cause of neonatal morbidity and mortality. Adoption of screening for maternal genital tract colonization and intrapartum antibiotic prophylaxis has significantly reduced early-onset neonatal GBS infections. For women with an allergy to penicillin, recommended agents for prophylaxis have been well-outlined, but compliance with guideline recommendations is poor. There have been ongoing efforts in vaccine development, but no vaccination currently is available for either preconception or antenatal administration. This article will review established screening techniques, intrapartum antibiotic prophylactic regimens, and management specifically of the penicillin-allergic pregnant woman who is colonized with GBS.

Sensitivity of prenatal ultrasound for detection of trisomy 18.

Objectives: To evaluate the sensitivity of prenatal ultrasound (US) for trisomy (T18) diagnosis and describe US findings in a large tertiary care institution in the USA. Materials and methods: This was a retrospective cohort of all T18 cases diagnosed at our institution from October 2004 to October 2014 based on prenatal or postnatal genetic diagnostic testing. We included all women with a fetus affected by T18 who had a comprehensive US by a maternal-fetal medicine specialist performed at our institution. US findings were reviewed, classified by organ system, and categorized as an anomaly or soft marker. Chi-square or t-test was used for statistical analysis. Results: We included 128 cases of T18 with confirmed cytogenetic analysis -110 (86%) of which were diagnosed prenatally or suspected by cell-free DNA and confirmed postnatally, and 18 of which underwent neonatal blood sampling alone. One hundred and twenty-one (95%) had at least one abnormal US finding. Anomalies were more frequently identified on US at ≥20 weeks as compared with <20 weeks (93% versus 76%; p = .004). The mean number of findings detected per fetus was 5.1 ± 3.0. Fetuses diagnosed by postnatal sampling alone had a similar number of US exams performed and number of abnormal findings compared to those diagnosed prenatally. Conclusion: Ninety-five percent of fetuses with T18 had at least one abnormal US finding. This sensitivity of is higher than reported in most prior studies, but is not 100%, and should be considered when counseling women regarding prenatal diagnosis of T18. Rationale: Historical detection rates for abnormal sonographic findings in trisomy 18 fetuses range from 70% to 100%. These studies are limited by small sample sizes. This is a contemporary study of ultrasound findings in a large group of women with confirmed trisomy 18 by prenatal or postnatal genetic diagnosis. We provide expansive detail on soft markers and anomalies broken down by organ-system and gestational age.

Evaluating Fundal Dominant Contractions on Spatiotemporal Electrohysterography as a Marker for Effective Labor Contractions.

OBJECTIVE: To evaluate if fundal (F) dominance of the electrohysterogram is associated with vaginal delivery and lack of F dominance is associated with cesarean for labor dystocia. STUDY DESIGN: We conducted a prospective cohort study of nulliparous women in spontaneous labor at ≥36 weeks. Clinicians were blinded to electrohysterography data which were in addition to standard cardiotocography. All contractions in the hour preceding diagnosis of complete cervical dilation (for women delivering vaginally) or the hour preceding the decision for cesarean were analyzed. RESULTS: Of 224 patients, 167 had evaluable data. The proportion of F dominant contractions was not different for women undergoing cesarean for labor dystocia (n = 11) compared with all others (n = 156)-88.7 ± 10.2 versus 86.0 ± 11.4%; p = 0.44. Results were similar when comparing the cesarean for labor dystocia group to those undergoing cesarean for other indications (n = 10) and vaginal deliveries (n = 146)-88.7 ± 10.2 versus 86.5 ± 10.0 versus 85.9 ± 11.5%; p = 0.74. CONCLUSION: We were unable to confirm our earlier finding that F dominance of the electrohysterogram is associated with vaginal delivery and lack of F dominance is associated with cesarean for dystocia.