Download PDF
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
1   Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands
,
Mieke ten Eikelder
2   Department of Obstetrics and Gynecology, Groene Hart Hospital, Gouda, The Netherlands
,
Katrien Oude Rengerink
3   Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands
,
Christianne de Groot
4   Department of Obstetrics, VU Medical Center, Amsterdam, The Netherlands
,
Hanneke Feitsma
5   Department of Obstetrics and Gynecology, Haga Hospital, the Hague, The Netherlands
,
Marc Spaanderman
6   Department of Obstetrics, Maastricht University Medical Center, Maastricht, The Netherlands
,
Mariëlle van Pampus
7   Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
,
Jan Willem de Leeuw
8   Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, The Netherlands
,
Ben Willem Mol
3   Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands
,
Kitty Bloemenkamp
1   Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands
,
on behalf of the PROBAAT Study Group › Author Affiliations
Further Information

Publication History

14 January 2013

07 February 2013

Publication Date:
05 April 2013 (online)

    Permissions and Reprints

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
 

  • 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
    PubMedGoogle Scholar
  • 2 Martin JA, Hamilton BE, Ventura SJ , et al. Births: final data for 2009. Natl Vital Stat Rep 2011; 60: 1-70
    PubMedGoogle Scholar
  • 3 EURO-PERISTAT Project European Perinatal. Health Rep 2008. Available at: www.europeristat.com . Accessed on March 15, 2013
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 5 Guidline Development Group RCOG. NICE Guideline Induction of Labour. 2001. London, UK: Royal College of Obstetricians and Gynaecologists;
    Google Scholar
  • 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
    PubMedGoogle Scholar
  • 7 Comissie Richtlinjen NVOG. Inductie van de baring Guidline. Utrecht, The Netherlands: Nederlandse vereniging voor Obstetrie en Gynaecologie; 2006
    Google Scholar
  • 8 Thiery M. Ripening procedures. Eur J Obstet Gynecol Reprod Biol 1988; 28: 95-102
    CrossrefPubMedGoogle Scholar
  • 9 Hofmeyr GJ, Gülmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev 2010; (10) CD000941
    PubMedGoogle Scholar
  • 10 Arias F. Pharmacology of oxytocin and prostaglandins. Clin Obstet Gynecol 2000; 43: 455-468
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 12 Goldberg AB, Greenberg MB, Darney PD. Misoprostol and pregnancy. N Engl J Med 2001; 344: 38-47
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 15 Alfirevic Z, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev 2006; (2) CD001338
    PubMedGoogle Scholar
  • 16 Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK: The Cochrane Collaboration and John Wiley & Sons Ltd.; 2009
    Google Scholar
  • 17 The Cochrane Collaboration Review Manager (RevMan) Version 5.,.2013. Available at: http://ims.cochrane.org/revman . Accessed on March 15, 2013
    PubMed
  • 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
    PubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 23 Greybush M, Singleton C, Atlas RO, Balducci J, Rust OA. Preinduction cervical ripening techniques compared. J Reprod Med 2001; 46: 11-17
    PubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 35 McKenna DS, Duke JM. Effectiveness and infectious morbidity of outpatient cervical ripening with a Foley catheter. J Reprod Med 2004; 49: 28-32
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 37 Bennett BB. Uterine rupture during induction of labor at term with intravaginal misoprostol. Obstet Gynecol 1997; 89 (5 Pt 2) 832-833
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar