Marta Jozwiak1, Mieke ten Eikelder2, Katrien Oude Rengerink3, Christianne de Groot4, Hanneke Feitsma5, Marc Spaanderman6, Mariëlle van Pampus7, Jan Willem de Leeuw8, Ben Willem Mol3, Kitty Bloemenkamp1. 1. Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands. 2. Department of Obstetrics and Gynecology, Groene Hart Hospital, Gouda, The Netherlands. 3. Department of Obstetrics, Academic Medical Center, Amsterdam, The Netherlands. 4. Department of Obstetrics, VU Medical Center, Amsterdam, The Netherlands. 5. Department of Obstetrics and Gynecology, Haga Hospital, the Hague, The Netherlands. 6. Department of Obstetrics, Maastricht University Medical Center, Maastricht, The Netherlands. 7. Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 8. Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, The Netherlands.
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. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
RCT Entities:
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. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Authors: Soe-Na Choo; Abhiram Kanneganti; Muhammad Nur Dinie Bin Abdul Aziz; Leta Loh; Carol Hargreaves; Vikneswaran Gopal; Arijit Biswas; Yiong Huak Chan; Ida Suzani Ismail; Claudia Chi; Citra Mattar Journal: BMJ Open Date: 2019-11-06 Impact factor: 2.692
Authors: Marieke Dt de Vaan; Mieke Lg Ten Eikelder; Marta Jozwiak; Kirsten R Palmer; Miranda Davies-Tuck; Kitty Wm Bloemenkamp; Ben Willem J Mol; Michel Boulvain Journal: Cochrane Database Syst Rev Date: 2019-10-18