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Comparison of intravenous oxytocin infusion versus intracervical dinoprostone rupture of membranes: A randomized controlled trial
Maria Ines A. Garcia, MD and Leah Socorro N. Rivera, MD, FPOGS, FPSMFM
Department of Obstetrics and Gynecology, University of Santo Tomas Hospital
Objective: To compare two protocols for labor induction in pregnant women with prelabor rupture of membranes (PROM).
Population: Subjects were recruited from the University of Santo Tomas Hospital (Private Division and Clinical Division). Pregnant women with a live, term, singleton fetus, cephalic presentation, a reactive Non stress test, who presented with PROM and a Bishop score of ?5, with no previous Cesarean section, or other uterine surgery.
Methodology: This is a two-arm superiority, open label, randomized controlled trial. Pregnant women with a live, term, singleton fetus, cephalic presentation, a reactive Non stress test, who presented with PROM and a Bishop score of ?5, and with no previous Cesarean section or other uterine surgery were randomly assigned to receive either intravenous (IV) oxytocin infusion or intracervical dinoprostone 0.5 mg gel followed 6 hours later by IV oxytocin infusion.
Results: Vaginal delivery within 24 hours of labor induction increased significantly with intracervical dinoprostone gel followed by IV oxytocin infusion (87% versus 61%; RR: 1.43; 95% CI: 0.99 – 2.06; P<0.044). Comparable result was observed for nulliparous women included in the study population. The time interval from labor induction to active phase was significantly shorter in the dinoprostone-oxytocin group than in the oxytocin alone group (2.4 ± 2.1 versus 6.3 ± 1.4 hours; p<0.001). The time interval from labor induction to delivery was also significantly shorter in the dinoprostoneoxytocin group (6.3 ± 1.5 versus 10.4 ± 1.4 hours; p<0.000). Cesarean delivery rates were statistically similar in the dinoprostone-oxytocin and oxytocin alone groups (17% versus 40%; p=0.102). The neonatal outcomes were comparable in both groups, except for birth weight.
Conclusion: Intracervical dinoprostone 0.5 mg gel followed 6 hours later by an oxytocin infusion in term women presenting with PROM and an unfavorable cervix (Bishop Score of 5 or less) was associated with a higher rate of vaginal delivery within 24 hours, shorter time interval from labor induction to active phase of labor, and shorter time interval from labor induction to delivery, and no difference in maternal and neonatal complications was observed compared with oxytocin infusion alone.