Katherine A. Connolly

A Randomized Trial of Foley Balloon Induction of Labor Trial in Multiparas (FIAT-M)

Background The optimal method of labor induction is not known. It is important to determine the safest and efficient method to minimize the length of labor, hospital stay, cost, and adverse outcomes. Objective This study aims to determine if induction of labor with simultaneous use of oxytocin and Foley balloon versus the sequential use of Foley balloon followed by oxytocin decreases the time to delivery in multiparous women. Study Design We conducted a randomized controlled trial of multiparous women who presented for induction of labor at Mount Sinai from December 2013 to April 2016. Patients were admitted for induction with indications determined by their provider. Women with a nonanomalous, singleton fetus ≥ 24 weeks in vertex presentation with intact membranes were offered participation. Exclusion criteria included the history of uterine surgery, unexplained vaginal bleeding, latex allergy, or contraindication to vaginal delivery. Participants were randomized to either simultaneous (oxytocin and Foley balloon) or sequential (oxytocin after the expulsion of Foley balloon) induction group. The primary outcome was the time from induction to delivery. Secondary outcomes included mode of delivery, estimated blood loss (EBL), postpartum hemorrhage (PPH), chorioamnionitis, and composite neonatal outcome. Maternal and neonatal outcomes were collected via chart review. Analyses were done on an intention‐to‐treat basis. Results A total of 142 patients were enrolled; 75 in the simultaneous and 67 in the sequential group. There were no differences in baseline characteristics in the two groups. There was no difference in median time to delivery between groups (10.7 vs. 10.6 hours, p = 0.44). There was no difference in the rate of cesarean delivery, EBL, PPH, chorioamnionitis, or composite neonatal outcome. Conclusion Simultaneous use of oxytocin and Foley balloon for induction of labor does not decrease time to delivery in multiparas.

Maternal clinical disease characteristics and maternal and neonatal outcomes in twin and singleton pregnancies with severe preeclampsia

OBJECTIVE Based on anecdotal observations, there is concern that severe preeclampsia leads to greater morbidity and mortality for mothers and neonates of twin pregnancies than for mothers and neonates of singleton pregnancies. Because few studies have been done, this study compared maternal disease characteristics and maternal/neonatal clinical outcomes of twin and singleton pregnancies complicated by severe preeclampsia. STUDY DESIGN An historical cohort study of patients hospitalized at the Mount Sinai Hospital in New York City, NY, USA, from 2006 to 2010, compared 63 twin and 339 singleton pregnancies complicated by severe preeclampsia via chart review. Women were analyzed in two groups: hospitalized ≤34 weeks gestational age (GA) and hospitalized >34 weeks GA. Univariable analysis (using Chi-square test, Fishers Exact test, Students t-test, or Wilcoxon Rank-Sum test, as appropriate) then multivariable analysis (using multivariable linear regression or multivariable logistic regression, as appropriate) compared maternal disease characteristics and maternal/neonatal clinical outcomes in twin and singleton pregnancies. RESULTS Women with twins were older [mean age 34.9 years (standard deviation (SD) 7.9 years) vs. 29.4 years (SD 7.4 years), P-value<.001] and women with singletons had a higher prevalence of chronic hypertension (21% vs. 8%, P=.02) and higher prevalence of history of preeclampsia (13% vs. 2%, P=.006). Women with twins were admitted for severe preeclampsia at an earlier gestational age (GA) [median twin 34.9 weeks GA (interquartile range, IQR, 32.7, 36.1) vs. median singleton 37.1 weeks GA (IQR 35.0, 38.9), P<.001]. Among women presenting ≤34 weeks GA (27 twins; 108 singletons), women with singletons had a higher mean systolic blood pressure (BP) (181.1 vs. 163.5, P<.001), higher mean diastolic BP (108.4 vs. 100.1, P=.002), and higher prevalence of headache (56% vs. 30%, P=.02). Among women presenting >34 weeks GA (36 twins; 231 singletons), women with singletons had a higher prevalence of headache (54% vs. 28%, P=.004). CONCLUSION Mothers and neonates of twin pregnancies complicated by severe preeclampsia do not appear to have greater morbidity and mortality compared to mothers and neonates of singleton pregnancies complicated by severe preeclampsia.

Cervical Ripening Using Foley Balloon with or without Oxytocin: A Systematic Review and Meta-Analysis

Objective To assess available evidence regarding the use of oxytocin in conjunction with Foley balloon (FB) for cervical ripening. Methods Databases from MEDLINE (U.S. National Library of Medicine, 1980—May 12, 2017), MEDLINE (Ovid, 1980—June 30, 2017), the Cochrane Library Controlled Trials Register, ClinicalTrials.gov, and Web of Science were queried for studies on FB cervical ripening with or without oxytocin in pregnant women. Search terms included: “balloon dilatation” OR “mechanical methods” OR “mechanical method” OR “mechanical dilation” OR “mechanical dilatation” OR “mechanical dilations” OR “mechanical dilatations” OR “balloon” OR “Foley” AND “Pitocin” OR “oxytocin.” All relevant references were reviewed. Literature for inclusion and methodological quality were reviewed based on the Preferred Reporting Items for Systematic Review and Meta‐Analysis guidelines. Results Out of 344 citations, six randomized clinical trials (1,133 patients) fulfilled our inclusion criteria. The pooled estimate showed that the cesarean delivery (CD) rate did not differ (relative risk [RR]: 0.91 (95% confidence interval [CI] [0.76‐1.10]; p = 0.23) between patients who underwent preinduction cervical ripening with FB alone versus those who received oxytocin in addition to FB. Heterogeneity was not significant among studies (I2 0.0%; p = 0.64). Furthermore, no differences in other outcomes such as composite and maternal outcomes were detected between these two groups. Compared with simultaneous use of oxytocin with FB, the Foley alone cervical ripening group had a longer induction to delivery time, and lower deliveries within 12 and 24 hours. Subgroup analysis showed that only multiparous women in the Foley alone group had lower rate of vaginal delivery within 24 hours (RR: 0.74, 95% CI [0.61‐0.89], p = 0.002) along with a trend toward higher CD rates. Conclusion Adding oxytocin to FB at the time of preinduction cervical ripening does not reduce cesarean rates nor improve maternal or neonatal outcomes. Multiparous women who received FB alone seem to have lower rates of vaginal deliveries within 24 hours, but these results should be interpreted with caution.