Comparison of Dinoprostone Controlled Release Vaginal Pessary with Dinoprostone Intracervical Gel for Preinduction Cervical Ripening and Induction of Labor at Term

A. Tempe, Sonia Sindher, Niharika Dhiman, Devender Kumar, P. Mishra
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Abstract

Context: There is limited experience of use of dinoprostone controlled release vaginal pessary in Indian scenario. Hence, we aim to find its efficacy for induction of labor (IOL). Aims: To compare two formulations of dinoprostone: intracervical gel and controlled release vaginal pessary for IOL. Settings and Design: Randomized controlled study in a tertiary care center. Methods: A double-blinded randomized controlled study was done on 106 women with singleton pregnancy, 37 to 41 weeks with vertex presentation, no obvious fetal compromise, and planned for IOL. They were randomly divided into equal groups to receive either dinoprostone intracervical gel (Group A) or dinoprostone controlled release vaginal pessary (Group B). The main outcome measures: change in Bishop score (using simplified Bishop score) at 0 to 6 hours and 6 to 12 hours after application and success to initiate active labor. The secondary outcome measures: maternal adverse effect, induction to delivery time, requirement of oxytocin infusion, cesarean section rate, APGAR score, and neonatal intensive care unit admission. Statistical Analysis: Statistical Package for Social Sciences (SPSS) version 17.0. Results: Increase in Bishop score and women achieving active labor were more in Group B (90.6% vs. 41.5%; P < 0.01). Mean time from induction to delivery was higher in Group A (19.72 hours vs. 12.53 hours; P < 0.01). Requirement of oxytocin was lesser in Group B (35.8% vs. 75.5%; P < 0.001). No adverse maternal or fetal outcome was noted in either of the groups. Conclusions: Dinoprostone controlled release vaginal pessary has significantly better outcomes than intracervical gel for IOL.
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地诺前列酮控释阴道支架与地诺前列醇宫颈内凝胶用于宫颈预成熟及足月引产的比较
背景:在印度,使用地诺前列酮控释阴道托的经验有限。因此,我们的目的是寻找其对引产(IOL)的疗效。目的:比较地诺前列酮的两种制剂:宫颈内凝胶和控释阴道人工晶状体托。设置和设计:在三级护理中心进行的随机对照研究。方法:对106例单胎妊娠妇女进行双盲随机对照研究,这些妇女在37至41周时有顶点表现,没有明显的胎儿损害,并计划进行人工晶状体植入。他们被随机分为两组,接受地诺前列酮宫颈内凝胶(A组)或地诺前列醇控释阴道托(B组)。主要结果指标:应用后0至6小时和6至12小时Bishop评分(使用简化的Bishop评分)的变化以及主动分娩的成功。次要转归指标:产妇不良反应、分娩时间、催产素输注需求、剖宫产率、APGAR评分和新生儿重症监护室入院率。统计分析:社会科学统计软件包(SPSS)17.0版。结果:B组毕晓普评分的增加和女性主动分娩的次数较多(90.6%对41.5%;P<0.01)。A组从引产到分娩的平均时间较高(19.72小时对12.53小时;P<0.01),B组对催产素的需求较少(35.8%对75.5%;P<0.001)。两组均未观察到不良的母体或胎儿结局。结论:地诺前列酮控释阴道人工晶状体栓的效果明显优于宫颈内凝胶。
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