Foley Catheter versus Vaginal Misoprostol: Randomized Controlled Trial (PROBAAT-M Study) and Systematic Review and Meta-Analysis of Literature

Marta Jozwiak; Mieke ten Eikelder; Katrien Oude Rengerink; Christianne de Groot; Hanneke Feitsma; Marc Spaanderman; Mariëlle van Pampus; Jan Willem de Leeuw; Ben Willem Mol; Kitty Bloemenkamp; on behalf of the PROBAAT Study Group

doi:10.1055/s-0033-1341573

American Journal of Perinatology, Table of Contents

Am J Perinatol 2014; 31(02): 145-156
DOI: 10.1055/s-0033-1341573

Original Article

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

Foley Catheter versus Vaginal Misoprostol: Randomized Controlled Trial (PROBAAT-M Study) and Systematic Review and Meta-Analysis of Literature

Marta Jozwiak

¹Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands

,

Mieke ten Eikelder

²Department of Obstetrics and Gynecology, Groene Hart Hospital, Gouda, The Netherlands

,

Katrien Oude Rengerink

³Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands

,

Christianne de Groot

⁴Department of Obstetrics, VU Medical Center, Amsterdam, The Netherlands

,

Hanneke Feitsma

⁵Department of Obstetrics and Gynecology, Haga Hospital, the Hague, The Netherlands

,

Marc Spaanderman

⁶Department of Obstetrics, Maastricht University Medical Center, Maastricht, The Netherlands

,

Mariëlle van Pampus

⁷Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

,

Jan Willem de Leeuw

⁸Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, The Netherlands

,

Ben Willem Mol

³Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands

,

Kitty Bloemenkamp

¹Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands

,

on behalf of the PROBAAT Study Group

› Author Affiliations

Abstract

Objectives To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor.

Study Design This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-μg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted.

Results Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p < 0.001). Meta-analysis showed no difference in cesarean delivery rate and reduced vaginal instrumental deliveries and hyperstimulation in the Foley catheter group. Other outcomes were not different.

Conclusion Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Keywords

cervical ripening - labor induction - Foley catheter - misoprostol - prostaglandin E1 - cesarean delivery rate

Full Text

References

References
1 The Health and Social Care Information Centre. NHS Maternity Statistics, England: 2009–10. Leeds: The information centre for health and social care. Available at: www.hesonline.nhs.uk . Accessed on March 15, 2013
2 Martin JA, Hamilton BE, Ventura SJ , et al. Births: final data for 2009. Natl Vital Stat Rep 2011; 60: 1-70
3 EURO-PERISTAT Project European Perinatal. Health Rep 2008. Available at: www.europeristat.com . Accessed on March 15, 2013
4 American College of Obstetricians Gynecologists. ACOG technical bulletin. Induction of labor. Number 217—December 1995 (replaces no. 157, July 1991). Int J Gynaecol Obstet 1996; 53: 65-72
5 Guidline Development Group RCOG. NICE Guideline Induction of Labour. 2001. London, UK: Royal College of Obstetricians and Gynaecologists;
6 Reyer MDM, de Leeuw JW. Hoe wordt in Nederland ingeleid bij een onrijpe cervix?. Nederlands Tijdschrift voor obstetrie en gynaecologie 2009; 5: 142-146
7 Comissie Richtlinjen NVOG. Inductie van de baring Guidline. Utrecht, The Netherlands: Nederlandse vereniging voor Obstetrie en Gynaecologie; 2006
8 Thiery M. Ripening procedures. Eur J Obstet Gynecol Reprod Biol 1988; 28: 95-102
9 Hofmeyr GJ, Gülmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev 2010; (10) CD000941
10 Arias F. Pharmacology of oxytocin and prostaglandins. Clin Obstet Gynecol 2000; 43: 455-468
11 Jozwiak M, Oude Rengerink K, Benthem M , et al; PROBAAT Study Group. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. Lancet 2011; 378: 2095-2103
12 Goldberg AB, Greenberg MB, Darney PD. Misoprostol and pregnancy. N Engl J Med 2001; 344: 38-47
13 Weeks A, Alfirevic Z, Faúndes A, Hofmeyr GJ, Safar P, Wing D. Misoprostol for induction of labor with a live fetus. Int J Gynaecol Obstet 2007; 99 (Suppl. 02) S194-S197
14 Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev 2012; 3: CD001233
15 Alfirevic Z, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev 2006; (2) CD001338
16 Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK: The Cochrane Collaboration and John Wiley & Sons Ltd.; 2009
17 The Cochrane Collaboration Review Manager (RevMan) Version 5.,.2013. Available at: http://ims.cochrane.org/revman . Accessed on March 15, 2013
18 Dionne MD, Dube J, Chaillet N. Randomized study comparing Foley catheter and intravaginal misoprostol as cervical ripening. Am J Obstet Gynecol 2011; 204: S48
19 Kashanian M, Fekrat M. The cervical ripening and induction of labor with intravaginal misoprostol, traction on the cervix with intracervical Foley catheter, and a combination of the two methods: a randomized trial of 3 techniques. Int J Gynaecol Obstet 2009; 107: S481
20 Lemyre M, Verret N, Turcot LL, Brassard N, Morin V. Foley catheter or vaginal misoprostol for cervical ripening: a randomized controlled trial. Am J Obstet Gynecol 2006; 195: S105
21 Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol 2003; 189: 1031-1035
22 Deo S, Iqbal B, Das V, Agarwal A, Singh R. Evaluation of non-pharmacological method-transcervical Foley catheter to intravaginal misoprostol and prostaglandin E2 gel for preinduction cervical ripening. Biomed Res 2012; 23: 247-252
23 Greybush M, Singleton C, Atlas RO, Balducci J, Rust OA. Preinduction cervical ripening techniques compared. J Reprod Med 2001; 46: 11-17
24 Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective, randomized controlled trial comparing misoprostol, Foley catheter, and combination misoprostol-Foley for labor induction. Am J Obstet Gynecol 2003; 187: 1031-1035
25 Kandil M, Emarh M, Sayyed T, Masood A. Foley catheter versus intra-vaginal misoprostol for induction of labor in post-term gestations. Arch Gynecol Obstet 2012; 286: 303-307
26 Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand 2010; 89: 1045-1052
27 Oliveira MV, Oberst PV, Leite GK , et al. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet 2010; 32: 346-351
28 Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG 2008; 115: 1443-1450
29 Roudsari FV, Ayati S, Ghasemi M, Shakeri MT, Farshidi F, Shahabian M. Comparison of vaginal misoprostol with Foley catheter for cervical ripening and induction of labor. Iran J Pharm Res 2011; 10: 149-154
30 Sheikher C, Suri N, Kholi U. Comparative evaluation of oral misoprostol, vaginal misoprostol and intracervical Foley's catheter for induction of labour at term. JK Science 2009; 11: 75-77
31 Fox NS, Saltzman DH, Roman AS, Klauser CK, Moshier E, Rebarber A. Intravaginal misoprostol versus Foley catheter for labour induction: a meta-analysis. BJOG 2011; 118: 647-654
32 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: 1239-1245
33 Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol 2004; 191: 1632-1636
34 Rouse DJ, Weiner SJ, Bloom SL , et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Failed labor induction: toward an objective diagnosis. Obstet Gynecol 2011; 117 (2 Pt 1) 267-272
35 McKenna DS, Duke JM. Effectiveness and infectious morbidity of outpatient cervical ripening with a Foley catheter. J Reprod Med 2004; 49: 28-32
36 Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol 2001; 98 (5 Pt 1) 751-756
37 Bennett BB. Uterine rupture during induction of labor at term with intravaginal misoprostol. Obstet Gynecol 1997; 89 (5 Pt 2) 832-833
38 Choy-Hee L, Raynor BD. Misoprostol induction of labor among women with a history of cesarean delivery. Am J Obstet Gynecol 2001; 184: 1115-1117
39 Cunha M, Bugalho A, Bique C, Bergström S. Induction of labor by vaginal misoprostol in patients with previous cesarean delivery. Acta Obstet Gynecol Scand 1999; 78: 653-654
40 Plaut MM, Schwartz ML, Lubarsky SL. Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section. Am J Obstet Gynecol 1999; 180 (6 Pt 1) 1535-1542
41 Wing DA, Lovett K, Paul RH. Disruption of prior uterine incision following misoprostol for labor induction in women with previous cesarean delivery. Obstet Gynecol 1998; 91 (5 Pt 2) 828-830
42 Bujold E, Blackwell SC, Gauthier RJ. Cervical ripening with transcervical Foley catheter and the risk of uterine rupture. Obstet Gynecol 2004; 103: 18-23
43 Ravasia DJ, Wood SL, Pollard JK. Uterine rupture during induced trial of labor among women with previous cesarean delivery. Am J Obstet Gynecol 2000; 183: 1176-1179