地诺前列酮栓剂与地诺前列酮凝胶用于引产和新生儿结局的比较研究

Pranjali Rai, Rashmi M D
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引用次数: 0

摘要

本研究比较了两种地诺前列酮制剂(一种栓剂和一种凝胶)的安全性和有效性。2018 年 8 月至 2020 年 5 月期间,迈苏鲁阿波罗医院 BGS 开展了一项回顾性随机观察研究,比较地诺前列酮控释栓剂和地诺前列酮凝胶对宫颈不利的妇女进行足月引产的效果。在研究参与者中,50 名准妈妈接受了地诺前列酮缓释剂,50 名妇女接受了地诺前列酮凝胶引产。对两组进行了比较和结果分析。研究的主要结果是引产到分娩的间隔时间、阴道分娩成功率、阴道分娩手术需求和剖腹产需求。次要结果为新生儿发病率和子宫过度刺激。两组引产后的 Bishop 评分均有明显改善(p=<0.001)。如果仅比较两种制剂的引产后评分,栓剂比凝胶制剂更有助于改善毕晓普评分(或有助于宫颈成熟),因此有助于提高阴道分娩的机会(因为栓剂组引产后毕晓普评分有明显变化)。栓剂组从诱导到分娩的平均间隔时间为(11.03±4.648)小时,凝胶组为(21.18±9.127)小时,P 值显著<0.005。与凝胶组相比,栓剂组诱导后的 Bishop 评分显著改善,诱导到分娩的时间更短。分娩方式的差异不显著。幸运的是,两种产品都没有对母亲或胎儿产生严重的副作用。两种地诺前列酮制剂对于足月引产都是安全的。不过,相对而言,栓剂能以更短的引产时间实现更高的自然阴道分娩率。此外,地诺前列酮还具有给药方便、一次性使用、减少感染机会等优点。
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A comparative study between dinoprostone pessary and dinoprostone gel for induction of labor and neonatal outcome
This study compares the safety and efficacy of two dinoprostone formulations – a pessary and a gel. A retrospective randomised observational study was conducted to compare Dinoprostone controlled release pessary and Dinoprostone gel for induction of labor at term in women with unfavourable cervix at Apollo Hospitals BGS, Mysuru during August 2018 – May 2020. Among study participants 50 expectant mothers received Dinoprostone pessary while 50 women received Dinoprostone gel for induction of labour. Both groups were compared and the outcomes were analysed. The primary outcomes of the study were induction to delivery interval, successful vaginal delivery, need for operative vaginal delivery and need for caesarean section. Secondary outcomes were observed for neonatal morbidity and uterine hyperstimulation. There was a significant (p=<0.001) improvement in Bishop scores after induction in both groups. When only the post-induction scores for the two formulations were compared, the pessary helped to improve the bishops score (or helps in cervical ripening) better than the gel formulation and therefore can help to improve the chances of vaginal delivery(because there is a significant change in post induction bishop score in pessary group). The mean interval from induction to delivery for the pessary group was 11.03±4.648 hours and for the gel it was 21.18±9.127 hours with a significant p value <0.005The pessary showed a significant improvement in the post-induction Bishop score and a shorter induction to delivery time compared to the gel. Differences in the mode of delivery were not significant. Fortunately, no serious side effects to the mother or fetus were observed with both products. Both formulations of dinoprostone are safe for induction of labor at term. However, pessary achieves comparitively a higher rate of spontaneous vaginal delivery with a shorter labor induction time. Ease of administration, single application and thus decreased chance of infections are its additional benefits.
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