title: Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature.
abstract: OBJECTIVE
  To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Marta
authors.initials: M
authors.lastname: Jozwiak
authors.affiliation: Department of Obstetrics and Gynecology, Groene Hart Hospital, Gouda, The Netherlands.
authors.forename: Mieke
authors.initials: M
authors.lastname: ten Eikelder
authors.affiliation: Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Katrien
authors.initials: K
authors.lastname: Oude Rengerink
authors.affiliation: Department of Obstetrics, VU Medical Center, Amsterdam, The Netherlands.
authors.forename: Christianne
authors.initials: C
authors.lastname: de Groot
authors.affiliation: Department of Obstetrics and Gynecology, Haga Hospital, the Hague, The Netherlands.
authors.forename: Hanneke
authors.initials: H
authors.lastname: Feitsma
authors.affiliation: Department of Obstetrics, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Spaanderman
authors.affiliation: Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Mariëlle
authors.initials: M
authors.lastname: van Pampus
authors.affiliation: Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, The Netherlands.
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: de Leeuw
authors.affiliation: Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Ben Willem
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Kitty
authors.initials: K
authors.lastname: Bloemenkamp
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D011247:Pregnancy; D000282:Administration, Intravaginal; D002585:Cesarean Section / Q000706:statistics & numerical data; D036861:Delivery, Obstetric; D007751:Labor, Induced / Q000379:methods; D016595:Misoprostol / Q000008:administration & dosage; D010120:Oxytocics / Q000008:administration & dosage; D014546:Urinary Catheterization
chemical_list: D016595:Misoprostol; D010120:Oxytocics