Mélie Sarreau1,2, Helene Isly3,4, Patrice Poulain3,4, Brigitte Fontaine2, Olivier Morel5,6, Pascal Villemonteix7, Pierre Mares8,9, Eve Mousty8,9, Alain Godard10, Stephanie Ragot11,12,13, Fabrice Pierre1,11. 1. Department of Obstetrics and Gynecology, University Hospital of Poitiers, Poitiers, France. 2. Department of Obstetrics and Gynecology, Regional Hospital of Angoulême, Angoulême, France. 3. Department of Obstetrics and Gynecology, University Hospital of Rennes, Rennes, France. 4. Faculty of Medicine, University of Rennes, Rennes, France. 5. Department of Obstetrics and Gynecology, University Hospital, Nancy, France. 6. Faculty of Medicine, University of Lorraine, Nancy, France. 7. Department of Obstetrics and Gynecology, Regional Hospital of Nord de Sèvres, Bressuire, France. 8. Department of Obstetrics and Gynecology, University of Nîmes, Nîmes, France. 9. Faculty of Medicine, University of Nîmes, Nîmes, France. 10. Department of Obstetrics and Gynecology, General Hospital Camille Guérin, Chatellerault, France. 11. Faculty of Medicine, University of Poitiers, Poitiers, France. 12. Clinical Epidemiology and Health Research Center, University of Poitiers, Poitiers, France. 13. National Health and Medical Research Institute (INSERM), CIC 1402, Poitiers, France.
Abstract
INTRODUCTION: The aim of this study was to compare the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix. MATERIAL AND METHODS: This open-label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre-labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50-mL balloon catheter for 12 hours or a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications. RESULTS: The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score. CONCLUSIONS:Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.
RCT Entities:
INTRODUCTION: The aim of this study was to compare the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix. MATERIAL AND METHODS: This open-label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre-labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50-mL balloon catheter for 12 hours or a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications. RESULTS: The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score. CONCLUSIONS: Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.