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Background External genital warts are caused by various subtypes of the human papilloma virus and spread through direct skin-to-skin contact. Approximately 1% of the US population have external genital warts. Although cantharidin has been used to treat external genital warts for decades, there are no US Food and Drug Administration-approved cantharidin products and no reliable or controlled sources of cantharidin available. VP-102 is a drug-device combination product containing cantharidin (0.7% w/v) in a single-use shelf-stable applicator. Objective The objective of this randomized, double-blind, vehicle-controlled, phase II clinical trial was to determine the optimal regimen for the treatment, safety, and efficacy of VP-102 in external genital warts. Methods The study was conducted in two parts. Part A was dose finding and Part B was performed following the completion of Part A for a safety and efficacy evaluation. Following completion of Part A, 6-h and 24-h VP-102 regimens under occlusion were selected to be evaluated in Part B. Results Pooled results from Part B and Part A of the 6-h and 24-h VP-102 treatment regimens showed that 36.7% and 33.3% of participants achieved complete clearance of all treatable external genital warts at the end of treatment vs 4.2% (p < 0.0048) and 0% (p < 0.0075) with the vehicle. Adverse events experienced by the VP-102-treated participants were consistent with the pharmacodynamic action of cantharidin as a vesicant and were primarily mild to moderate in severity. The most common adverse events included application-site vesicles, pain, and erythema. No participants discontinued the study because of adverse events and no serious adverse events were deemed treatment related. Conclusions The adverse event profile and efficacy of VP-102 under occlusion demonstrated in this study support the conclusion that a 6-h or up to 24-h exposure regimen represents an acceptable risk:benefit profile and justifies the conduct of a larger vehicle-controlled phase III study in external genital warts. Clinical Trial Registration NCT03981822, actual study start date: 25 June, 2019; actual primary completion date: 21 May, 2020; actual study completion date: 8 July, 2020.

Our multi-institutional university consortium implemented a gastroschisis pathway in 2015 to standardize and improve care by promoting avoidance of routine intubation and paralysis during silo placement, expeditious abdominal wall closure, discontinuation of antibiotics/narcotics within 48 h of closure, and early initiation/advancement of feeds.Adherence to the gastroschisis pathway was prospectively monitored. Outcomes for the contemporary cohort (2015-2018) were compared with a historical cohort (2007-2012).Good adherence to the pathway was observed for 70 cases of inborn uncomplicated gastroschisis. The contemporary cohort had significantly lower median mechanical ventilator days (2 versus 5; p 0.01) and antibiotic days (5.5 versus 9; p 0.01) as well as earlier days to initiation of feeds (12 versus 15; p 0.01). However, no differences were observed in length of stay (28 versus 29 days; p = 0.70). A skin closure technique was performed in 66% of the patients, of which 46% were performed at bedside without intubation, the assistance of an operating-room team, or general anesthesia.In this study, adherence to a clinical pathway for gastroschisis across different facilities was feasible and led to reduction in exposure to mechanical ventilation and antibiotics. The adoption of a bedside skin closure technique appears to facilitate compliance with the pathway.Level II/III TYPE OF STUDY: Prospective comparative study with historical cohort.

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OBJECTIVES: To perform a multicenter study to assess growth failure in hospitalized infants with gastroschisis. STUDY DESIGN: This study included neonates with gastroschisis within sites in the University of California Fetal Consortium (UCFC). The study’s primary outcome was growth failure at hospital discharge, defined as a weight or length z-score decrease > 0.8 from birth. Regression analysis was performed to assess changes in z-scores over time. RESULTS: Among 125 infants with gastroschisis, the median gestational age was 37 weeks (IQR 35–37). Length of stay was 32 days (23–60); 55% developed weight or length growth failure at discharge (28% had weight growth failure, 42% had length growth failure, and 15% had both weight and length growth failure). Weight and length z-scores at 14 d, 30 d, and discharge were less than birth (p

© 2016 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc.OBJECTIVE: To estimate whether ultrasound measurement of the fetal adrenal gland remote from delivery in asymptomatic women can accurately predict spontaneous preterm birth. METHODS: We conducted a prospective multicenter observational nested cohort study of asymptomatic nulliparous women with a singleton pregnancy to study adverse pregnancy outcomes. Between 22 0/7 and 30 6/7 weeks of gestation, credentialed ultrasonographers measured the width (width), length (length), and, when able, depth (depth) of the "fetal zone" of the fetal adrenal gland as well as the width (Width), length (Length), and depth (Depth) of the total gland. We used the ratios of each measurement (width/Width, length/Length, and depth/Depth) to control for variation in adrenal size by gestational age. The accuracy of each ratio measurement in predicting spontaneous preterm birth at less than 37 0/7 weeks of gestation and spontaneous preterm birth at less than 34 0/7 weeks of gestation was assessed by receiver operating characteristic curves using area under the curve. RESULTS: Pregnancy outcomes were available for 1,697 women with one or more fetal adrenal gland measurements. Spontaneous preterm birth at less than 37 0/7 weeks of gestation and spontaneous preterm birth at less than 34 0/7 weeks of gestation occurred in 82 (4.8%) and six women (0.4%), respectively. None of the fetal adrenal gland measurements distinguished spontaneous preterm birth from term birth. The areas under the curve (95% confidence intervals) for spontaneous preterm birth at less than 37 0/7 weeks of gestation were 0.51 (0.45-0.58), 0.50 (0.44-0.56), and 0.52 (0.41-0.63) for width/Width, length/Length, and depth/Depth ratios, respectively. The areas under the curve for spontaneous preterm birth at less than 34 0/7 weeks of gestation were 0.52 (0.25-0.79) and 0.55 (0.31-0.79) for width/Width and length/Length ratios, respectively. Additionally, none of the means of the gland measurements were statistically different between those delivering at term and spontaneous at preterm (P>.05). CONCLUSION: Fetal adrenal size, as measured by ultrasonography between 22 0/7 and 30 6/7 weeks of gestation, is not predictive of spontaneous preterm birth in asymptomatic nulliparous women.

Preterm premature rupture of membranes (PPROM) complicates 3% of pregnancies and frequently results in preterm birth, often within 48 hours of membrane rupture. Our objective was to determine if subjects with PPROM between 24 and 31 (6)/ (7) weeks' gestation benefit from a 48-hour course of prophylactic indomethacin tocolysis. This was a double-masked randomized controlled trial. Subjects with PPROM between 24 and 31 (6)/ (7) weeks' gestation were randomized to receive indomethacin or placebo for 48 hours in addition to corticosteroids and latency antibiotics. The primary outcome of the study was delivery within 48 hours. Maternal and neonatal outcomes were also compared. This study was concluded prematurely due to slow accrual after a total of 50 subjects were enrolled. A total of 23/25 (92%) subjects in the indomethacin group remained pregnant beyond 48 hours compared with 20/22 (90.9%) in the placebo group (relative risk, 1.01; 95% confidence interval, 0.84 to 1.21). The latency period medians and interquartile ranges were similar between the two groups [indomethacin 193 (92 to 376.5) hours versus placebo 199 (77.5 to 459) hours, P = 0.91], and no differences were noted in any maternal or neonatal secondary outcomes. This limited study demonstrates no benefit with the use of prophylactic indomethacin tocolysis for women with PPROM.

Objective The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening. Study design A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation ≥28 weeks and an unfavorable cervix (Bishop score ≤6), were assigned to one of three groups: (1) intravaginal misoprostol 25 μg every 3 hours, (2) intracervical 16F Foley catheter, or (3) combination misoprostol–Foley catheter. Results Among 146 patients, 49 patients were assigned to misoprostol, 54 patients were assigned to Foley catheter, and 43 patients were assigned to combination therapy. There was no difference in vaginal delivery rates (misoprostol, 63.3%; Foley, 57.4%; combination, 58.1%; P =.81). There were also no statistically significant differences in the interval between induction to active phase, active phase to delivery, or induction to delivery among the three groups. Conclusion Intravaginal misoprostol and intracervical Foley catheter are comparable for preinduction cervical ripening. The combination of the two methods did not provide additional efficacy.

The purpose of this study was to describe morbidity, mortality, and developmental outcomes among extremely low-birth-weight infants (500-750 g).This retrospective cohort study included 167 live-born infants born at Long Beach Memorial Medical Center between January 1990 and December 1995.Mortality rates were 86% among infants600 g and 44% among thoseor =600 g, and the rate decreased with increasing gestational age. The absence of chorioamnionitis (P =.01) and the use of antepartum corticosteroids (P.0001) or neonatal surfactant (P =.0001) were associated with survival. Sixty-four percent of studied infants had respiratory distress syndrome, and 17% had grade III or IV intraventricular hemorrhage. Among the 63 survivors 57% were tested at 30 months of corrected age with the Bayley Scales of Infant Development. Mild or significant delays were seen on the mental development index in 68% of these cases and on the psychomotor development index in 58% of cases.Morbidity and mortality rates and the rate of developmental delay among infants with birth weights between 500 and 750 g were significant.

PREMATURE RUPTURE OF MEMBRANES AMIE HOLLARD, RHONDA FLORA, PAMELA RUMNEY, JUDITH CHUNG, MICHAEL NAGEOTTE, University of California, Irvine, Maternal Fetal Medicine, Lincoln, Nebraska, University of California, Irvine, Maternal Fetal Medicine, Orange, California, Long Beach Memorial Medical Center, Maternal Fetal Medicine, Long Beach, California OBJECTIVE: Methylenetetrahydrofolate reductase (MTHFR) plays a role in folate/homocysteine metabolism. The common polymorphisms in the MTHFR gene are C677T and A1298C, the presence of which has been associated with adverse pregnancy outcome. Given that folate and homocysteine are involved in collagen synthesis, we hypothesize the presence of MTHFR mutations in the fetus may increase the risk for preterm premature rupture of membranes (PPROM). STUDY DESIGN: A nested case control pilot study of 2 groups. Group I (n = 18): patients with PPROM delivering between 24 and 35 weeks. Group II (n = 25): patients without PPROM delivering between 24 and 42 weeks. Patients with diabetes, hypertension, preeclampsia, or multiple gestations were excluded. At delivery, a placental biopsy was obtained. The fetal RNA was extracted and multiplex PCR/ RFLP was performed for the presence of C677T and A1298C alleles. Univariate analysis, Chi-Square, Fisher’s Exact, & unpaired t tests were used as appropriate. Significance was set at P ! .05. RESULTS: The allele frequencies for C677T & A1298C are 28% & 44%, and 48% & 44% for Group I and Group II respectively . In Group II, there was an equal distribution of of the alleles between patients delivering at ! or >34 weeks gestation. In the Caucasion patients, 100% of Group I patients and only 60% of Group II patients had one or more mutations present. However, in the combined population there was no overall increased risk of PPROM if the fetus had one or more C677T P = .31) or A1298C mutations (P = .98). CONCLUSION: In our study, it appears that the presence of fetal C677T and A1298C polymorphisms are not uniquely associated with PPROM, but it may influence PPROM in certain ethnic groups. The effect of maternal genotype was not evaluated in this study, there may be additive effect when both genotypes are considered concurrently. An unexpected finding in this study was the large number of control patients with either mutation. A larger sample size is needed to discern if a true association is found between the presence of MTHFR mutations and PPROM. S112 SMFM Abstracts

PATIENTS WITH GESTATIONAL DIABETES MELLITUS K. JENNIFER VOSS, JUDITH CHUNG, PAMELA RUMNEY, KIRK KEEGAN, CAROL MAJOR, University of California, Irvine, Obstetrics & Gynecology, Orange, CA Long Beach Memorial Medical Center, Obstetrics & Gynecology, Long Beach, CA OBJECTIVE: Treatment of patients with gestational diabetes mellitus has not necessarily been shown to reduce the risk of macrosomia in this population. This study evaluates the contribution of potentially modifiable interventions that may help to reduce the risk of macrosomia in gestational diabetics. STUDY DESIGN: A retrospective cohort study (June 2001-December 2002) was performed using data from the California Department of Health Services, Maternal Child Health Branch, and the California Diabetes and Pregnancy Program Data System (the system collects data from all patients referred to the California Sweet Success Program). Logistic regression was performed to estimate the odds of macrosomia, defined as >4000 grams. The following factors were evaluated in the multivariate model: ethnicity, parity, education, gestational age at delivery, maternal weight, and the interaction between ethnicity and preferred language. RESULTS: Of 8790 patients, there were 6406 gestational diabetics that met inclusion criteria. The incidence of macrosomia was 11.6%. Ethnicity, preferred language, and the interaction of ethnicity and preferred language did not appear to be predictive of macrosomia. However, when compared to patients with a college education ormore, the odds ofmacrosomia in patients with a high school education were 1.53 (95% CI 1.24-1.90). In patients with less than a high school education, the odds were 1.79 (95% CI 1.34-2.38). CONCLUSION:Gestational diabetics with a lower level of education appear to have an increased risk of macrosomia. Interventions directed towards improving communication and knowledge of the disease process in such patients may prove to be beneficial. (This analysis, interpretation, and conclusion are that of the authors and not of the California Department of Health Services, Maternal Child Health Branch, or the California Diabetes and Pregnancy Program).