title: A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N).
abstract: BACKGROUND
  With an increasing rate of induction of labor, it is important to choose induction methods that are safe and efficient in achieving a vaginal delivery. The optimal method for inducing nulliparous women with an unfavorable cervix is not known.
  
  
  OBJECTIVE
  We sought to determine if induction of labor with simultaneous use of oxytocin and Foley balloon vs sequential use of Foley balloon followed by oxytocin decreases the time to delivery in nulliparous women.
  
  
  METHODS
  We conducted a randomized controlled trial of nulliparous women presenting for induction at a single institution from December 2013 through March 2015. After decision for induction was made by their primary provider, women with gestational age ≥24 weeks with a nonanomalous, singleton fetus in vertex presentation with intact membranes were offered participation. Exclusion criteria included 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 expulsion of Foley balloon) induction group. The primary outcome was time from induction to delivery. Secondary outcomes included mode of delivery, estimated blood loss, postpartum hemorrhage, 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 166 patients were enrolled; 82 in the simultaneous and 84 in the sequential group. There were no differences in baseline characteristics in the 2 groups. Patients who received simultaneous oxytocin with insertion of a Foley balloon delivered significantly earlier (15.92 vs 18.87 hours, P = .004) than those in the sequential group. There was no difference in rate of cesarean delivery, estimated blood loss, postpartum hemorrhage, chorioamnionitis, or composite neonatal outcome.
  
  
  CONCLUSIONS
  Simultaneous use of oxytocin and Foley balloon for induction of labor results in a significantly shorter interval to delivery in nulliparas.
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: Katherine.connolly@mssm.edu.
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Connolly
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, CT.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Kohari
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Patricia
authors.initials: P
authors.lastname: Rekawek
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Brooke S
authors.initials: BS
authors.lastname: Smilen
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Meredith R
authors.initials: MR
authors.lastname: Miller
authors.affiliation: Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Erin
authors.initials: E
authors.lastname: Moshier
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Stephanie H
authors.initials: SH
authors.lastname: Factor
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Joanne L
authors.initials: JL
authors.lastname: Stone
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Angela T
authors.initials: AT
authors.lastname: Bianco
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D002404:Catheterization; D020070:Cervical Ripening; D036861:Delivery, Obstetric; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D010120:Oxytocics / Q000627:therapeutic use*; D010121:Oxytocin / Q000627:therapeutic use*; D010298:Parity; D011247:Pregnancy; D013997:Time Factors
chemical_list: D010120:Oxytocics; D010121:Oxytocin
keywords: Foley balloon; induction of labor; oxytocin