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

Abstract

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.

Keywords

Foley balloon - induction of labor - oxytocin

Clinical Trial Registration

This trial is registered at clinicaltrials.gov (NCT02098421).

Note

This abstract was presented at the 37th Annual Pregnancy Meeting of the Society for Maternal Fetal Medicine; January 27, 2017 in Las Vegas, Nevada (abstract 746).

Funding

None.

• References

• 1 Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final data for 2014. Natl Vital Stat Rep 2015; 64 (12) 1-64
• 2 Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med 2005; 18 (03) 149-154
• 3 Burgess AP, Katz J, Pessolano J, Ponterio J, Moretti M, Lakhi NA. Determination of antepartum and intrapartum risk factors associated with neonatal intensive care unit admission. J Perinat Med 2016; 44 (05) 589-596
• 4 Ekin A, Gezer C, Solmaz U, Taner CE, Dogan A, Ozeren M. Predictors of severity in primary postpartum hemorrhage. Arch Gynecol Obstet 2015; 292 (06) 1247-1254
• 5 Dahlke JD, Mendez-Figueroa H, Maggio L. , et al. Prevention and management of postpartum hemorrhage: a comparison of 4 national guidelines. Am J Obstet Gynecol 2015; 213 (01) 76.e1-76.e10
• 6 von Gruenigen VE, Powell DM, Sorboro S, McCarroll ML, Kim U. The financial performance of labor and delivery units. Am J Obstet Gynecol 2013; 209 (01) 17-19
• 7 Shetty A, Burt R, Rice P, Templeton A. Women's perceptions, expectations and satisfaction with induced labour--a questionnaire-based study. Eur J Obstet Gynecol Reprod Biol 2005; 123 (01) 56-61
• 8 Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev 2012; 3 (03) CD001233 . Doi: 10.1002/14651858.CD001233.pub2
• 9 Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol 2008; 111 (06) 1320-1326
• 10 Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and pharmacologic methods of labor induction: a randomized controlled trial. Obstet Gynecol 2016; 128 (06) 1357-1364
• 11 Connolly KA, Kohari KS, Rekawek P. , et al. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol 2016; 215 (03) 392.e1-392.e6
• 12 Zhang J, Landy HJ, Branch DW. , et al; Consortium on Safe Labor. Contemporary patterns of spontaneous labor with normal neonatal outcomes. Obstet Gynecol 2010; 116 (06) 1281-1287
• 13 Dean AG, Sullivan KM, Soe MM. OpenEpi: Open Source Epidemiologic Statistics for Public Health, version 3.01a. Available at http://www.openepi.com
• 14 Delaney S, Shaffer BL, Cheng YW. , et al. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol 2010; 115 (06) 1239-1245
• 15 Saccone G, Berghella V. Induction of labor at full term in uncomplicated singleton gestations: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol 2015; 213 (05) 629-636