Pearlin R Chavakula1, Santosh J Benjamin1, Anuja Abraham1, Vaibhav Londhe1, Visalakshi Jeyaseelan2, Jiji E Mathews3. 1. Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India. 2. Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India. 3. Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India. Electronic address: og5@cmcvellore.ac.in.
Abstract
OBJECTIVE: To compare 25μg of vaginal misoprostol with a Foley catheter for induction of labor (IOL) for fetal growth restriction. METHODS: A randomized controlled trial was conducted in a tertiary center in South India. Women with fetal growth restriction (n=100) were randomized to be induced with three doses of vaginal misoprostol (25μg) every 6hours or with an intracervical Foley catheter, inserted 12hours before rupture of membranes, and oxytocin if needed. The primary outcome was uterine tachysystole with fetal cardiotocography abnormalities. Secondary outcomes pertained to effectiveness, complications, and patient satisfaction. RESULTS: One woman in the misoprostol group and none in the Foley catheter group had uterine tachysystole. The duration of labor from IOL to delivery was similar in both groups (P=0.416). More women in the misoprostol group had a vaginal delivery within 12hours (26.1% versus 5.6%; P=0.005). Women induced with misoprostol were less likely to deliver by lower-segment cesarean delivery (15.2% versus 29.6%; P=0.168) and to require oxytocin augmentation (60.9% versus 85.2%; P=0.007). Complications were few in both group. CONCLUSION:Few women had uterine tachysystole with cardiotocography abnormalities. Vaginal misoprostol at 25μg was more effective than a Foley catheter for IOL in fetal growth restriction. Clinical Trials Registry India:CTRI/2014/02/004411.
RCT Entities:
OBJECTIVE: To compare 25μg of vaginal misoprostol with a Foley catheter for induction of labor (IOL) for fetal growth restriction. METHODS: A randomized controlled trial was conducted in a tertiary center in South India. Women with fetal growth restriction (n=100) were randomized to be induced with three doses of vaginal misoprostol (25μg) every 6hours or with an intracervical Foley catheter, inserted 12hours before rupture of membranes, and oxytocin if needed. The primary outcome was uterine tachysystole with fetal cardiotocography abnormalities. Secondary outcomes pertained to effectiveness, complications, and patient satisfaction. RESULTS: One woman in the misoprostol group and none in the Foley catheter group had uterine tachysystole. The duration of labor from IOL to delivery was similar in both groups (P=0.416). More women in the misoprostol group had a vaginal delivery within 12hours (26.1% versus 5.6%; P=0.005). Women induced with misoprostol were less likely to deliver by lower-segment cesarean delivery (15.2% versus 29.6%; P=0.168) and to require oxytocin augmentation (60.9% versus 85.2%; P=0.007). Complications were few in both group. CONCLUSION: Few women had uterine tachysystole with cardiotocography abnormalities. Vaginal misoprostol at 25μg was more effective than a Foley catheter for IOL in fetal growth restriction. Clinical Trials Registry India:CTRI/2014/02/004411.
Authors: Joshua I Rosenbloom; Janine S Rhoades; Candice L Woolfolk; Molly J Stout; Methodius G Tuuli; George A Macones; Alison G Cahill Journal: J Matern Fetal Neonatal Med Date: 2019-04-24
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