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

Lauren T. Gallagher; Benjamin Gardner; Mahbubur Rahman; Corina Schoen; Katherine A. Connolly; Gary D. Hankins; George R. Saade; Antonio F. Saad

doi:10.1055/s-0038-1668577

American Journal of Perinatology, Table of Contents

Am J Perinatol 2019; 36(04): 406-421
DOI: 10.1055/s-0038-1668577

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Lauren T. Gallagher

¹Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas

,

Benjamin Gardner

¹Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas

,

Mahbubur Rahman

²Support Unit for Conducting Clinically Essential Studies, OMURA Susumu & Mieko Memorial, St. Luke's Center for Clinical Academia, St. Luke's International University, Tokyo, Japan

,

Corina Schoen

³Division of Maternal-Fetal Medicine, University of Massachusetts-Baystate, Springfield, Massachusetts

,

Katherine A. Connolly

⁴Division of Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, New York

,

Gary D. Hankins

¹Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas

,

George R. Saade

¹Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas

,

Antonio F. Saad

¹Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas

› Author Affiliations

Abstract

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 (I ² 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.

Keywords

preinduction - oxytocin - Foley - cervical ripening - induction - labor - cesarean

Full Text

References

References
1 Centers for Disease Control and Prevention. Recent declines in induction of labor. Available at: https://www.cdc.gov/nchs/products/databriefs/db155.htm . Accessed November 17, 2017
2 Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev 2012; (03) CD001233
3 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
4 El Khouly NI. A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix. J Obstet Gynaecol 2017; 37 (03) 309-314
5 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
6 Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley catheter with and without oxytocin for labor induction: a randomized controlled trial. Obstet Gynecol 2017; 129 (06) 1046-1053
7 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
8 Connolly KA, Kohari KS, Factor SH. , et al. A randomized trial of Foley balloon induction of labor trial in multiparas (FIAT-M). Am J Perinatol 2017; 34 (11) 1108-1114
9 Moher D, Liberati A, Tetzlaff J, Altman DG. ; PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. BMJ 2009; 339: b2535
10 Higgins JPT, Green S. , eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available at: www.cochrane-handbook.org . Accessed November 17, 2017
11 Moher D, Liberati A, Tetzlaff J, Altman DG. ; PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. PLoS Med 2009; 6 (07) e1000097
12 Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 2005; 5: 13
13 Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002; 21 (11) 1539-1558
14 DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986; 7: 177-188
15 Lipsey MW, Wilson DB. Practical Meta-analysis. Thousand Oaks: Sage; 2001