TY - JOUR
T1 - Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature
AU - Jozwiak, Marta
AU - ten Eikelder, Mieke
AU - Oude Rengerink, Katrien
AU - de Groot, Christianne
AU - Feitsma, Hanneke
AU - Spaanderman, Marc
AU - van Pampus, Mariëlle
AU - de Leeuw, Jan Willem
AU - Mol, Ben Willem
AU - Bloemenkamp, Kitty
PY - 2014
Y1 - 2014
N2 - To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. 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. 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. 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
AB - To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. 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. 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. 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
U2 - https://doi.org/10.1055/s-0033-1341573
DO - https://doi.org/10.1055/s-0033-1341573
M3 - Article
C2 - 23564065
SN - 0735-1631
VL - 31
SP - 145
EP - 156
JO - American journal of perinatology
JF - American journal of perinatology
IS - 2
ER -