Outcomes in low-risk patients before and after an institutional policy offering 39-week elective induction of labor.

OBJECTIVE: Elective induction of labor versus expectant management at 39 weeks gestation in low-risk nulliparous patients was shown in the ARRIVE randomized trial of over 6000 patients to decrease risks of cesarean delivery without significant change in the composite perinatal outcome. We aimed to pragmatically analyze the effect of offering elective induction of labor (eIOL) to all low-risk patients. METHODS: Retrospective cohort study of low-risk nulliparous and multiparous patients delivering live, non-anomalous singletons at a single center at greater than or equal to 39 0/7 weeks gestational age. Those with prior or planned cesarean delivery, ruptured membranes, medical comorbidities, or contraindications to vaginal delivery were excluded. Patients were categorized as before (pre-eIOL; 1/2012-3/2014) or after (post-eIOL; 3/2019-12/2021) an institution-wide policy offering eIOL at 39 0/7 weeks. Births occurring April 2014 to December 2018 were allocated to a separate cohort (during-eIOL) given increased exposure to eIOL as our center recruited participants for the ARRIVE trial. The primary outcome was cesarean birth. Secondary outcomes included select maternal (e.g. chorioamnionitis, operative delivery, postpartum hemorrhage) and neonatal morbidities (e.g. birthweight, small- and large-for gestational age, hypoglycemia). Characteristics and outcomes were compared between the pre and during-eIOL, and pre and post-eIOL groups; adjusted OR (95% CI) were calculated using multivariable regression. Subgroup analysis by parity was planned. RESULTS: Of 10,758 patients analyzed, 2521 (23.4%) were pre-eIOL, 5410 (50.3%) during-eIOL, and 2827 (26.3%) post-eIOL. Groups differed with respect to labor type, age, race/ethnicity, marital and payor status, and gestational age at care entry. Post-eIOL was associated with lower odds of cesarean compared to pre-eIOL (aOR 0.83 [95% CI 0.72-0.96]), which was even lower among those specifically undergoing labor induction (aOR 0.58 [0.48-0.70]. During-eIOL was also associated with lower odds of cesarean compared to pre-eIOL (aOR 0.79 [0.69-0.90]). Both during and post-eIOL groups were associated with higher odds of chorioamnionitis, operative delivery, and hemorrhage compared to pre-eIOL. However, only among post-eIOL were there fewer neonates weighing ≥4000 g, large-for-gestational age infants, and neonatal hypoglycemia compared to pre-IOL. CONCLUSION: An institutional policy offering eIOL at 39 0/7 to low-risk patients was associated with a lower cesarean birth rate, lower birthweights and lower neonatal hypoglycemia, and an increased risk of chorioamnionitis and hemorrhage.

Predicting peripartum infection in laboring patients at high risk in Cameroon, Africa.

OBJECTIVE: To develop a predictive model for peripartum infection among high risk laboring patients in Cameroon, Africa. STUDY DESIGN: We conducted a secondary analysis of the Cameroon Antibiotic Prophylaxis Trial (NCT03248297), a multicenter 3-arm double-blind randomized controlled trial of oral azithromycin ± amoxicillin among term pregnancies with prolonged labor or rupture of membranes in Cameroon 1/2018-5/2020. Patients with chorioamnionitis prior to randomization, study drug contraindications, or planned cesarean were excluded. The outcome of interest was a composite of maternal peripartum infection (chorioamnionitis, endometritis, sepsis by World Health Organization criteria, wound infection/abscess) diagnosed up to 6 weeks postpartum. Potential predictors were compared between patients with and without the composite outcome, and evaluated at a 0.05 alpha level. Statistically significant exposures were analyzed using multivariable regression (to generate adjusted odds ratios and 95 % confidence intervals) with backwards selection to generate a parsimonious model. Receiver operating characteristic curves with associated area under the curve assessed the model's predictive ability. A nomogram based on the final best fit multivariable model was constructed. RESULTS: Of 756 patients in the parent trial, 652 were analyzed: 45 (7 %) had peripartum infection. Those with infection were more likely to be nulliparous, lower education level, higher gestational age, receive antibiotics per hospital protocols, and undergo cesarean. In our best-fit multivariable model, none/primary education (vs university), cesarean birth, and antibiotic receipt per physician discretion (vs for cesarean prophylaxis) were significantly associated with increased infection risk. This model was moderately predictive (AUC = 0.75, 95 % CI 0.67-0.82). When using this 3 factor model, for a patient with a cesarean birth, receipt of antibiotics per physician discretion, and university education, the probability of peripartum infection was 35 % (95 % CI 0.11-0.73). CONCLUSIONS: While several variables such as parity are associated with infectious morbidity within 6 weeks among high risk laboring patients in Cameroon, only education level, antibiotic indication, and cesarean birth were independently associated, and a model including these 3 factors was moderately predictive. Validation of our findings in a larger population is warranted.

Maternal and Neonatal Outcomes at Periviable Gestation throughout Delivery Admission.

OBJECTIVE: The threshold of viability, as well as cutoffs for delivery interventions and neonatal resuscitation, vary by hospital and involve complex counseling. With improvements in neonatal resuscitation and intensive care, the threshold of viability has been decreasing. Decisions regarding delivery planning and neonatal resuscitation efforts should be based on the best available evidence. Our objective was to characterize survival rates and neonatal outcomes following periviable birth at different milestones beginning with prenatal admission through 1 year of life in a contemporary cohort. STUDY DESIGN: We performed a retrospective cohort study of all inborn infants without major congenital anomalies who delivered at the University of Alabama at Birmingham from 2013 to 2019 at gestational ages 22+0/7 to 25+6/7. Our primary outcome was to compared survival milestones throughout the pre- and postdelivery periods and neonatal complications in surviving newborns through 1 year of life at each gestational age. RESULTS: The survival rate to 1 year of life was 49% (48-56%, 95% confidence interval [CI]) for the entire cohort and varied according to gestational age at delivery (22 weeks 15% [10-23%, 95% CI], 23 weeks 48% [43-58%, 95% CI], 24 weeks 57% [52-67%, 95% CI], 25 weeks 71% [67-82%, 95% CI]). Overall for the entire cohort, the rate of lung disease requiring respiratory support at discharge was 51%, intraventricular hemorrhage was 42%, retinopathy of prematurity was 74%, pulmonary hypertension was 30%, and concerns for cerebral palsy at 1 year of life was 25%. All outcomes improved with advancing gestational age at delivery. Of infants who delivered during the 22nd week of gestation, 50% received antenatal corticosteroids. Infants exposed to antenatal corticosteroids had more interventions, less pulmonary hypertension, and improved survival to 1 year of life. CONCLUSION: Knowledge of maternal complications, longitudinal survival rates, and neonatal outcomes of periviable deliveries according to gestational age throughout the admission enhances obstetric and perinatal counseling after hospital admission. KEY POINTS: · Periviable birth outcomes at different delivery milestones is important for counseling.. · Providing contemporary outcomes for periviable deliveries is critical for accurate counseling.. · Administration of antenatal corticosteroids at 22 weeks' gestation appears beneficial overall..

Outpatient Foley Catheter for Induction of Labor in Obese Nulliparous Patients: A Secondary Analysis of OFFSITE II Randomized Controlled Trial.

OBJECTIVE: In the OFFSITE II randomized controlled trial, outpatient cervical ripening with a Foley catheter (CF) in nulliparous patients undergoing elective induction of labor (eIOL) shortened the time from admission to delivery. Given that patients with obesity have protracted labor and higher rates of failed IOL, we sought to determine if outpatient ripening with a CF may be even more beneficial for this high-risk group. STUDY DESIGN: We performed a secondary analysis of the OFFSITE II randomized controlled trial. For this analysis, all patients from the primary trial were classified by their intervention assignment (inpatient vs. outpatient) and also by their admission body mass index (BMI) class (BMI ≥ 30 and BMI < 30 kg/m2). The primary outcome was time from labor and delivery (L&D) admission to delivery. Secondary outcomes included cesarean delivery, time from admission to hospital discharge, and rates of clinically diagnosed chorioamnionitis and endometritis. RESULTS: In patients with BMI ≥ 30, the primary outcome, time from admission to delivery, (18.0 [13.5-20.9] vs. 20.4 [16.6-31.3] hours, p = 0.01), as well as total hospitalization length (3.2 [2.5-3.3] vs. 3.4 [3.1-4.3] days, p = 0.02) were shorter in the outpatient group. There were no differences in rates of chorioamnionitis or endometritis in outpatient compared with inpatient CF. Furthermore, in those with a BMI ≥ 30, the cesarean rate was significantly lower with outpatient CF (19.4% vs. 44.7%, p = 0.03); it was not statistically different in patients with BMI < 30. CONCLUSION: In this exploratory retrospective secondary analysis of the OFFSITE II randomized control trial, we found that in patients with BMI ≥ 30 undergoing eIOL, outpatient CF was associated with a lower time from L&D admission until delivery. This was also associated with a shorter time of total hospital duration and decreased the rate of cesarean, a benefit not detected in the overall analysis presented in the primary study. In nulliparas undergoing induction of labor, ripening with outpatient cervical Foley may even more significantly reduce labor duration, total hospital duration, and the rate of cesarean in patients with obesity. KEY POINTS: · Outpatient CF was associated with a lower time from L&D admission until delivery in obese nulliparas.. · Outpatient CF was associated with a shorter time of total hospital duration in obese nulliparas.. · Outpatient CF was associated with a decreased rate of cesarean birth in obese nulliparas..

Early Gestational Diabetes Screening Based on ACOG Guidelines.

OBJECTIVE: A recent randomized controlled trial suggested that early gestational diabetes mellitus (GDM) screening in patients with obesity (body mass index [BMI] ≥30 kg/m2) does not improve perinatal outcomes. The American College of Obstetrics and Gynecology currently recommends early screening for gestational diabetes in patients who are overweight with one or more additional risk factors. We evaluated the effect of screening based on the number of additional risk factors for development of gestational diabetes. STUDY DESIGN: This was a secondary analysis of a multicenter randomized controlled trial of obese patients with singleton nonanomalous fetuses comparing early (14-20 weeks' gestation) with routine (24-28 weeks' gestation) GDM screening. Exclusion criteria were pregestational diabetes, major medical illnesses, bariatric surgery, chronic steroid use, and prior cesarean. Early versus routine GDM screening groups were compared and stratified by the number of additional risk factors for GDM (0, 1, 2, and ≥3). The primary outcome was an adverse perinatal composite outcome composed of: macrosomia, primary cesarean delivery, hypertensive disorders of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia. Analyses examined effects of early versus routine screening by the number of additional risk factors and their possible interaction on the incidences of the primary outcome and GDM. RESULTS: Of 913 patients, 5% had 0, 52% had 1, 33% had 2, and 10% had ≥3 additional risk factors. Baseline characteristics, including the number and type of risk factors, were similar between early and routine screening groups. Breslow-Day test for interaction between early versus routine screening and the number of additional risk factors was not significant for either the primary outcome (p = 0.37) or the diagnosis of GDM (p = 0.28). The incidence of GDM and the adverse perinatal composite outcome increased as the number of risk factors increased (p < 0.001). CONCLUSION: In patients with BMI ≥30 kg/m2 and additional risk factors, early GDM screening does not prevent adverse outcomes. KEY POINTS: · The ACOG currently recommends early screening for gestational diabetes if patients have risk factors.. · Even in patients with multiple risk factors, early screening for GDM does not improve outcomes.. · Patients with three or more risk factors may have worse outcomes if they undergo early screening..

Participation in obstetrical studies is associated with improved pregnancy outcomes.

BACKGROUND: The association between pregnant patients participating in obstetrical studies and pregnancy outcomes is understudied. OBJECTIVE: This study aimed to evaluate the association between participation in obstetrical studies and maternal and neonatal outcomes. STUDY DESIGN: This was a retrospective cohort study of all patients delivering at a single center from 2013 to 2018. Patients with pregnancy loss at <13 weeks of gestation or major fetal anomalies were excluded. Patients who enrolled in one or more obstetrical studies were categorized as "study participants" and were compared with patients who did not enroll in an obstetrical study, that is, "study nonparticipants." The primary outcome was a composite of maternal morbidity diagnosed up to 6 weeks after delivery. The secondary outcomes included composite neonatal morbidity and other perinatal outcomes. Bivariate analyses compared baseline demographics and outcomes between groups. Multivariable logistic regression was used to estimate adjusted odds ratios with 95% confidence intervals. Subgroup analyses by study design (trial or observational) were planned. RESULTS: Of 19,569 patients included in this analysis, 3848 (19.7%) were study participants, and 15,721 (80.3%) were study nonparticipants. Among study participants, 3023 (78.6%) enrolled in a trial, and 825 (21.4%) enrolled in an observational study. The study participants had higher body mass index and were more likely to be younger, non-Hispanic Black, publicly insured, nulliparous, and undergo cesarean delivery than study nonparticipants. Compared with study nonparticipants, the study participants had significantly lower odds of composite maternal morbidity (9.2% vs 8.7%; adjusted odds ratio, 0.83; 95% confidence interval, 0.73-0.95) and composite neonatal morbidity (27.5% vs 18.6%; adjusted odds ratio, 0.53; 95% confidence interval, 0.48-0.58). In addition, the odds of fetal death, 5-minute Apgar score of <5, neonatal death, maternal and neonatal intensive care unit admissions, and lengths of stay were lower for study participants than for study nonparticipants. In stratified analyses, maternal morbidity was only significantly decreased among trial participants; however, there was a significantly reduced odds of neonatal morbidity, regardless of study design (trial or observational vs no study). CONCLUSION: Participation in obstetrical studies was associated with decreased maternal and neonatal morbidities after adjusting for potential confounders. This underscored the importance of pregnant patients enrolling in obstetrical clinical studies and potentially benefiting from the additional surveillance. Further study of how study participation exerts this effect on pregnancy outcomes is warranted.

Timing of Maternal Discharge after Cesarean Delivery and Risk of Maternal Readmission.

OBJECTIVE: Despite legislation and hospital policies (present in some institutions) mandating a minimum length of stay in an effort to decrease the frequency of hospital readmissions, the effectiveness of this approach remains uncertain.We hypothesized that following cesarean delivery (CD), the rates of maternal readmission or unscheduled health care visits are lower in patients discharged on postoperative day (POD) 3 or ≥4 as compared with those discharged earlier on POD 2. METHODS: This is a secondary analysis of a multicenter randomized trial comparing adjunctive azithromycin for unscheduled CD to prevent infection. Groups were compared based on the duration of hospitalization measured in days from delivery (POD 0) to day of discharge and categorized as POD 2, 3, and ≥4. The primary outcome was the composite of any maternal postpartum readmission, unscheduled clinic, or emergency room (ER) visit, within 6 weeks of delivery. Secondary outcomes included components of the primary outcome and neonatal readmissions. We excluded women with hypertensive disorders of pregnancy and infections diagnosed prior to POD 2. RESULTS: A total of 1,391 patients were included. The rate of the primary outcome of any readmission increased with POD at discharge: 5.9% for POD 2, 9.4% for POD 3, and 10.9% for POD ≥4 group (trend for p = 0.03). The primary outcome increased with later discharge (POD ≥4 when compared with POD 2). Among components of the composite, ER and unscheduled clinic visits, but not maternal readmissions, increased with the timing of discharge for patients discharged on POD ≥4 when compared with POD 2. Using logistic regression, discharge on POD 3 and on POD ≥4 was significantly associated with the composite (adjusted odds ratios [aOR] 2.6, 95% confidence interval [CI] [1.3-5.3]; aOR 2.9, 95% CI [1.3-6.4], respectively) compared with POD 2. CONCLUSION: The risk of maternal readmission composite following uncomplicated but unscheduled CD was not lower in patients discharged home on POD 3 or ≥4 compared with patients discharged earlier (POD 2). KEY POINTS: · Risk of maternal readmission is higher in patients discharged on POD 3 or 4 compared with POD 2.. · No significant differences by the timing of discharge were observed for any neonatal readmissions.. · Timing of discharge should include an individualized approach with the option of discharge by POD 2..

Contemporary Test Performance of the Random Urine Protein-to-creatinine Ratio.

OBJECTIVE: The random urine protein-to-creatinine ratio (UPCR) is a screening test used for predicting clinically significant proteinuria (urine protein ≥ 300 mg) during pregnancy. No consensus exists on the optimal random UPCR cutoff for performing follow-up 24 hour urine (24H) total protein collection. We aim to evaluate the test performance of random UPCR in predicting proteinuria in a contemporary cohort. STUDY DESIGN: This was a retrospective cohort study of pregnant patients at our institution from 2014 to 2018 with a random UPCR and follow-up 24H protein collection. The primary analysis estimated the test characteristics (sensitivity, specificity, positive and negative predictive values) of using random UPCR for the detection of proteinuria defined as urine protein ≥300 mg on 24H protein collection. UPCR cutoffs from 0.10 to 0.30 mg/dL were evaluated, receiver operator characteristic (ROC) curve was constructed, and area under the curve (AUC) was determined. A secondary analysis examined the correlation between UPCR and 24H protein using least squares regression and Pearson correlation. RESULTS: Paired UPCR and 24H collection results were available for 1,120 patients. Mean gestational age at time of UPCR was 31.1 ± 5.1 weeks and 687 (61.3%) of patients had a 24H ≥300 mg. UPCR <0.10 mg/dL effectively excluded proteinuria ≥300 mg on 24H collection, while UPCR ≥0.18 mg/dL correctly classifies proteinuria with 91% sensitivity, 57% specificity, 77% positive predictive value, and 79% negative predictive value. UPCR ≥1.07 mg/dL had 100% specificity for 24 hour proteinuria. The area under ROC curve was 0.86. UPCR and 24H collection were highly correlated with a Pearson correlation coefficient of 0.85. After our institution lowered the threshold to obtain a 24H from UPCR ≥0.20 mg/dL to ≥0.10 mg/dL in May 2017, the percentage of patients meeting criteria for 24H collection increased from 57.8 to 84.4%. CONCLUSION: The AUC and Pearson correlation suggest random UPCR is a high performance test for the prediction of proteinuria on 24H. Optimal test performance is dependent upon clinical consideration and upon the implications of the disease or condition. A random UPCR screen positive threshold of 0.18 mg/dL maximizes sensitivity to identify clinically significant proteinuria. KEY POINTS: · Random urine protein to creatinine ratio is a high performance test for proteinuria.. · A random UPCR threshold of 0.18 mg/dL maximizes sensitivity to identify proteinuria.. · Optimal test performance is dependent on the disease or clinical condition..

Quantifying the additional maternal morbidity in women with preeclampsia with severe features in whom immediate delivery is recommended.

BACKGROUND: Preeclampsia with severe features when diagnosed at less than 34 weeks is associated with maternal morbidity and is managed by immediate delivery or inpatient expectant management. OBJECTIVE: This study aimed to compare maternal morbidity in women with preeclampsia with severe features in whom the American College of Obstetricians and Gynecologists recommends immediate delivery versus those eligible for expectant management. STUDY DESIGN: This was a retrospective cohort study of women with preeclampsia with severe features delivered between 23 to 34 weeks of gestation from 2013 to 2017 at a single tertiary center. Women were categorized into 2 groups: (1) those recommended by the American College of Obstetricians and Gynecologists for immediate delivery, that is, ineligible for expectant management, and (2) those eligible for expectant management. The primary outcome was composite postpartum maternal morbidity, which included maternal intensive care unit admission, stroke, death, and other severe morbidities. The secondary outcomes included select adverse perinatal outcomes. Groups were compared and adjusted odds ratios (95% confidence intervals) calculated. RESULTS: Of the 1172 women with preeclampsia identified during the study period, 543 with preeclampsia with severe features were included for analysis: 211 (39%) were ineligible for expectant management and 332 (61%) were eligible for expectant management. Baseline characteristics, including age, body mass index, race and ethnicity, parity, marital status, and gestational age at preeclampsia diagnosis, were similar between the 2 groups. Women ineligible for expectant management had significantly higher composite postpartum maternal morbidity (adjusted odds ratio, 5.02 [95% confidence interval, 1.35-18.69]). In addition, those ineligible for expectant management were more likely to have postpartum intensive care unit admission (adjusted odds ratio, 4.19 [95% confidence interval, 1.09-16.16]) and postpartum hemoglobin level of <7 g/dL (adjusted odds ratio, 5.07 [95% confidence interval, 1.35-19.08]). There was no demonstrable difference in neonatal outcomes between the 2 groups. CONCLUSION: Women with preeclampsia with severe features who were ineligible for expectant management per the American College of Obstetricians and Gynecologists guidelines had a 5-fold increased risk of maternal morbidity, confirming the need for escalation of care and delivery without delay.

Outcomes before and after Adopting Guidelines for Expectant Management of Severe Preeclampsia.

OBJECTIVE: This study aimed to compare maternal and neonatal outcomes in women with severe preeclampsia before and after implementation of the American College of Obstetricians and Gynecologists (ACOG) taskforce hypertensive guidelines. STUDY DESIGN: Single-center retrospective cohort study of women with severe preeclampsia delivering live nonanomalous singletons 23 to 342/7 weeks from 2013 to 2017. In 2015, the ACOG guidelines for expectant management of severe preeclampsia were implemented at our institution. Based on this, patients were categorized as preguideline (January 2013-December 2015) or postguideline adoption (January 2016-December 2017). Primary outcomes included composite maternal morbidity and composite neonatal morbidity; secondary outcomes included composite components, length of stay, birth weight, and delivery gestational age. Groups were compared with Student's t-test, Chi-square, and Wilcoxon's rank-sum tests; adjusted odds ratios (aOR; 95% confidence intervals [CIs]) were calculated. Yearly composite outcomes were compared using the Cochran-Armitage trend test. We estimated a sample size of 250 per group would provide 80% power at α = 0.05 to detect a 50% reduction in neonatal morbidity from a baseline rate of 21.5%. RESULTS: From 2013 to 2017, a total of 543 women with severe preeclampsia were identified: 278 (51%) preguideline and 265 (49%) postguideline. Baseline characteristics were overall similar between groups. There were no significant differences in maternal (aOR = 0.96, 95% CI: 0.6-1.41) or neonatal (aOR = 0.88, 95% CI: 0.61-1.28) composite morbidity between groups. Furthermore, there were no differences in composite maternal or neonatal morbidity over time. CONCLUSION: Perinatal outcomes were similar before and after implementation of severe preeclampsia management guidelines at our institution. Studies to evaluate if benefits are limited to subsets of this population, such as earlier gestational ages, are needed. KEY POINTS: · Expectant management of severe preeclampsia has yet to be fully evaluated outside of trial conditions.. · We did not see a significant improvement in neonatal composite morbidity/mortality.. · We also did not see a worsened composite maternal morbidity/mortality..

Skin preparation type and post-cesarean infection with use of adjunctive azithromycin prophylaxis.

OBJECTIVE: To compare the frequency of postoperative surgical site infection (SSI) by type of skin preparation used for unscheduled cesarean in the setting of adjunctive azithromycin prophylaxis. METHODS: Secondary analysis of a multi-center randomized controlled trial of adjunctive azithromycin (500 mg intravenous) versus placebo in women who were ≥24 weeks gestation and undergoing unscheduled cesarean (i.e. during labor or ≥4 h after membrane rupture). Type of skin preparation used was identified based on the protocol at the hospital at the time of delivery: iodine-alcohol, chlorhexidine, chlorhexidine-alcohol, or the combination of chlorhexidine-alcohol and iodine. The primary outcome of this analysis was incidence of post-operative SSI, as defined by CDC criteria. Multivariable logistic regression was applied for adjustments. RESULTS: All 2013 women in the primary trial were included in this analysis. Women were grouped according to type of skin preparation received: iodine-alcohol (n = 193), chlorhexidine (n = 733), chlorhexidine-alcohol (n = 656), and chlorhexidine-alcohol and iodine combined sequentially (n = 431). The unadjusted rates of wound infection ranged from 2.9% to 5.7%. Using iodine-alcohol as the referent, the adjusted odds ratios for wound SSI were 0.71 (95% CI 0.30-1.66) for chlorhexidine, 0.97 (95% CI 0.41-2.28) for chlorhexidine-alcohol, and 0.88 (95% CI 0.36-2.20) for chlorhexidine-alcohol with iodine combination. CONCLUSION: In women undergoing unscheduled cesarean delivery in a trial of adjunctive azithromycin, the type of skin preparation used did not appear to be associated with the frequency of wound SSI.

Single Dose of Oral Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection in Laboring, High-Risk Women in Cameroon: A Randomized Controlled Trial.

OBJECTIVE: To compare the effectiveness of single-dose azithromycin, with or without amoxicillin, with placebo to prevent peripartum infection in laboring women. METHODS: We conducted a multicenter, three-group, double-blind randomized controlled trial of women with viable term nonanomalous pregnancies with either prolonged labor of 18 hours or longer or rupture of membranes for 8 hours or longer in Cameroon. Women with chorioamnionitis before randomization, study drug contraindications, or planned cesarean births were excluded. Women were randomized to oral azithromycin 1 g-placebo (group 1), oral azithromycin 1 g-oral amoxicillin 2 g (group 2), or placebo-placebo (group 3). All groups received usual care, including antibiotics given at the health care professional's discretion. The primary outcome was a composite of maternal peripartum infection or death from any cause up to 6 weeks postpartum. Two primary comparisons (group 1 vs group 3 and group 2 vs group 3) were planned. We estimated that 241 women per group (planning for 750 total) would provide 80% power at two-sided α=0.05 (0.025 per comparison) to detect a 50% effect size assuming 20% baseline composite infection rate. RESULTS: From January 6, 2018, to May 15, 2020, 6,531 women were screened, and 756 (253 in group 1, 253 in group 2, and 250 in group 3) were randomized. Baseline characteristics (including body mass index, duration of rupture of membranes or labor, and parity) were balanced across groups, except for maternal age. More than 60% of women in each group received usual-care antibiotics: more than 90% penicillin and approximately 50% for prolonged rupture of membranes across all study groups. Composite outcome incidences were similar in antibiotic groups 1 (6%) and 2 (7%) compared with placebo group 3 (10%) (RR 0.6, 95% CI 0.3-1.2; 0.7, 95% CI 0.4-1.3, respectively). Chorioamnionitis and wound infection were significantly lower in group 2 (3.2% vs 0.4% and 4% vs 0.8% respectively, both P=.02) compared with group 3. There were no differences in other maternal or neonatal outcomes including neonatal infection. CONCLUSION: A single dose of oral azithromycin with or without amoxicillin for prolonged labor or rupture of membranes at term did not reduce maternal peripartum or neonatal infection. Observed lower than expected infection rates and frequent usual-care antibiotic use may have contributed to these findings. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03248297. FUNDING SOURCE: Merck for Mothers Investigator Studies Program grant.

Adolescent emergency contraception usage, knowledge, and perception.

OBJECTIVE: We sought to describe the current usage patterns, knowledge regarding, and perception of emergency contraception in adolescent patients. STUDY DESIGN: We surveyed female patients ages 14 to 21 seen at the Pediatric and Gynecology Clinic regarding emergency contraception. We posed questions to understand adolescent awareness, personal usage, and means of obtaining emergency contraception. We also explored respondent knowledge of emergency contraception and potential barriers to access. RESULTS: Of 261 patients approached, 253 completed the survey with a mean age of 16.7 ± 1.7 years. The majority of respondents (80.2%) had heard of oral emergency contraceptive pills. Among sexually active adolescents, 25.6 % reported personal use. Older adolescents (≥18 years) were more likely to have heard of emergency contraceptive pills, to know someone who used them, and to have used it themselves compared to younger adolescents (all p < 0.05). A minority of respondents knew that emergency contraception could be bought over the counter regardless of age or gender (44.3%) and that parental consent is not required (27.7%). Having ever been sexually active was associated with an increased odds of being correct with regards to the availability and timing of LNG EC. A history of LNG EC use was associated with an increased likelihood of understanding the mechanism of action and side effects of LNG EC. CONCLUSIONS: Though adolescents in our population were aware of emergency contraception, only a small portion had used it themselves. Misunderstandings regarding the availability and safety of emergency contraception were common in our population. IMPLICATIONS: Educating adolescents on the availability, safety, and mechanism of action of LNG EC may improve utilization of LNG EC in this population.

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..

Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial.

OBJECTIVE: To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery. METHODS: We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours. RESULTS: From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3-7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4-15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4-1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8-3.9, P=.16) were not significantly different between groups. CONCLUSION: In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery. CLINCAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03472937.

Labor Curve Analysis of Medically Indicated Early Preterm Induction of Labor.

OBJECTIVE: To analyze the labor curves of nulliparous and multiparous women between 23.0 and 34.0 weeks of gestation who underwent induction of labor and achieved vaginal delivery. METHODS: This is a retrospective cohort study of all live singletons delivered vaginally after medically indicated induction of labor between 23.0 and 34.0 weeks of gestation from 2011 through 2014 at our institution. We excluded those with one or no cervical examinations available during labor. Prior cesarean delivery, 5-minute Apgar score less than 5, and arterial cord pH less than 7.0 were exclusions. The course of cervical dilation was modeled using repeated measures analysis, and smoothed curves for nulliparous and parous women were generated separately. Estimates of the median (5th-95th percentile) traverse times between two dilations were computed using interval censored regression. Traverse times (ie, the elapsed time between two given dilation measures) were compared between nulliparous and parous women. RESULTS: Sixty-seven nulliparous and 69 multiparous women were included. Each group exhibited similar rates of change from 1 to 3 cm of dilation (median 3.6 hours nulliparous and 3.4 hours multiparous, P=.90). Nulliparous women progressed from 3 to 6 cm more slowly than multiparous women (median 10 hours vs 4.4 hours, P<.001). After 6 cm, both groups rapidly progressed to 10 cm (median 0.3 hours vs 0.3 hours, P=.64). Although the 95th percentile traverse time from 6 to 10 cm was about 2 hours in each group, progression from 1 to 6 cm at the 95th percentile was much longer (64.0 vs 42.2 hours). CONCLUSION: Early preterm labor induction takes less time in multiparous women owing to more rapid progression from 3 to 6 cm. At the 95th percentile, both nulliparous and multiparous women delivered vaginally, even with latent labor lasting well longer than 24 hours.

HIV Status and Other Risk Factors for Prevalent and Incident Sexually Transmitted Infection during Pregnancy (2000-2014).

Background: Sexually transmitted infections (STIs) are associated with adverse birth outcomes. Current prenatal STI screening guidelines define "risk" without explicit consideration of HIV status. Our objective was to test the hypothesis that HIV status is associated with bacterial STI in pregnant women. Methods: We designed a retrospective cohort study to identify pregnant women with HIV who delivered at our facility during 2000-2014. HIV+ women were compared to HIV- women with matching by year of delivery. Logistic regression was used to model adjusted odds of prevalent and incident STI. Prevalent STI was defined as chlamydia (CT), gonorrhea (GC), syphilis, or trichomoniasis detected on an initial prenatal screening test and incident STI as a newly positive result following a negative prenatal test. Results: The cohort included 432 women, 210 HIV+ and 222 HIV-. Most pregnant women were screened for STI (92% of HIV+ women and 74% of HIV- women). STI rates were high and particularly elevated in HIV+ women: 29% vs 18% (p=0.02), for prevalent STI and 11% vs 2% (p<0.001) for incident STI. Risk factors for prevalent STI were as follows: HIV status (aOR 3.0, CI: 1.4-6.4), Black race (aOR 2.7, 95% CI: 1.1-6.6), and more recent delivery (2007-2014 compared to 2000-2006) (aOR 2.3, CI: 1.1-4.7). HIV status was an independent risk factor for incident STI (aOR 7.2, CI: 2.1-25.0). Conclusion: Pregnant women who delivered in our center had high STI rates. Since HIV infection was independently associated with prevalent and incident STI, prenatal screening guidelines may need to incorporate HIV status as a high-risk group for repeat testing.

Impact of Azithromycin-Based Extended-Spectrum Antibiotic Prophylaxis on Noninfectious Cesarean Wound Complications.

OBJECTIVE: Adding azithromycin to standard antibiotic prophylaxis for unscheduled cesarean delivery has been shown to reduce postcesarean infections. Because wound infection with ureaplasmas may not be overtly purulent, we assessed the hypothesis that azithromycin-based extended-spectrum antibiotic prophylaxis also reduces wound complications that are identified as noninfectious. STUDY DESIGN: This is a secondary analysis of the C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) randomized controlled trial, which enrolled women with singleton pregnancies ≥24 weeks who were undergoing nonelective cesarean. Women were randomized to adjunctive azithromycin or identical placebo up to 1 hour preincision. All wound complications occurring within 6 weeks were adjudicated into infection and noninfectious wound complications (seroma, hematoma, local cellulitis, and other noninfectious wound breakdown). The primary outcome for this analysis is the composite of noninfectious wound complications. RESULTS: At a total of 14 sites, 2,013 women were randomized to adjunctive azithromycin (n = 1,019) or placebo (n = 994). Groups were similar at baseline. Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant (p = 0.22). CONCLUSION: While adding azithromycin to usual antibiotic prophylaxis for nonelective cesarean delivery does reduce the risk of postcesarean infections, it did not significantly reduce the risk of postcesarean noninfectious wound complications.

Azithromycin-based Extended-Spectrum Antibiotic Prophylaxis for Cesarean: Role of Placental Colonization with Genital Ureaplasmas and Mycoplasmas.

OBJECTIVE: To explore whether the effect of azithromycin (AZI) on postcesarean infections varied by the presence/absence of genital mycoplasmataceae placental colonization. STUDY DESIGN: This was a single-center substudy of multicenter double-blind C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) trial of women randomized to AZI or placebo (+cefazolin) antibiotic prophylaxis at cesarean. Chorioamnion/placenta specimens were tested for genital mycoplasmataceae colonization by polymerase chain reaction. Primary outcome was a composite of endometritis, wound infection, or other infections up to 6 weeks postpartum. Analysis was intent-to-treat; logistic regression was used to evaluate interactions between treatment assignment (AZI/placebo) and the presence/absence of mycoplasmataceae and to quantify effects of AZI in analyses stratified by the presence/absence of these microorganisms. RESULTS: Specimens from 613 women (303 AZI and 310 placebo) were evaluated. Baseline characteristics were similar between groups, and approximately 1/3 (30.3%) had mycoplasmataceae placental/chorioamnion colonization. There was no evidence of effect modification (p interaction = 0.79) between treatment assignment and the presence/absence of organisms. Stratified analyses showed fewer events in the AZI group in the presence (odds ratio [OR]: 0.42; 95% confidence interval [CI]: 0.17-1.01) and absence (OR: 0.49; 95% CI: 0.24-1) of mycoplasmataceae. Results were similar with endometritis/wound infections and with ureaplasmas/mycoplasmas considered separately. CONCLUSION: The reduction in postcesarean infection with AZI does not vary based on the presence or absence of genital mycoplasmataceae placental colonization.

Pregnancy Outcomes after Early Amniotomy among Class III Obese Gravidas Undergoing Induction of Labor.

OBJECTIVE: We sought to evaluate differences in pregnancy outcomes following early amniotomy in women with class III obesity (body mass index ≥40 kg/m2) undergoing induction of labor. STUDY DESIGN: This is a retrospective cohort study of women with class III obesity undergoing term induction of labor from January 2007 to February 2013. Early amniotomy was defined as artificial membrane rupture at less than 4 cm cervical dilation. The primary outcome was cesarean delivery. Secondary outcomes included length of labor, a maternal morbidity composite, and a neonatal morbidity composite. A subgroup analysis examined the effect of parity. Multivariable logistic regression was used to adjust for covariates. RESULTS: Of 285 women meeting inclusion criteria, 107 (37.5%) underwent early amniotomy and 178 (62.5%) underwent late amniotomy. Early amniotomy was associated with cesarean delivery after multivariable adjustments (adjusted odds ratio [aOR], 2.05; 95% confidence interval [CI], 1.21-3.47). There were no significant differences in length of labor or maternal and neonatal morbidity between groups. When stratified by parity, early amniotomy was associated with increased cesarean delivery (aOR, 3.10; 95% CI, 1.47-6.58) only in nulliparous women. CONCLUSION: Early amniotomy among class III obese women, especially nulliparous women, undergoing labor induction may be associated with an increased risk of cesarean delivery.