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临床试验/CTIS2022-501142-30-00
CTIS2022-501142-30-00招募中1 期

Balloon + Oxytocin versus Oral Misoprostol to Induce labor in case of premature rupture of membranes (PROM) at term in nulliparous - PHRC N 2020 GALLOT

CHU Gabriel-Montpied0 个研究点目标入组 520 人开始时间: 2022年6月23日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
520

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • Age > 18 years old, Pregnant, Gestational age = 37 weeks, Singleton pregnancy with cephalic presentation, Nulliparous, PROM occurring = 37 weeks + 0 day and without labour beyond 12 hours, Unfavourable cervix (Bischop score < 6), Able to give her informed consent, Ability to comply with the requirement of the study, Covered by the French Social Security welfare system

排除标准

  • Unable to understand French language, Known HIV seropositivity, Placenta praevia, Fetal death, Abnormal FHR (Fetal Heart Rate), Contraindication to misoprostol, Contraindication to balloon, Contraindication to oxytocin, Patient subject to a legal protection order (curatorship or tutorship), Refusal to participate, Contraindication for vaginal delivery, Loss of meconium amniotic fluid (LA), Temperature > 38.2°C, Intrauterine infection, IUGR with Doppler anomaly, Fetus with expected polymalformative syndrome, Scarred womb, Suspicion of genital herpes

研究者

发起方
CHU Gabriel-Montpied

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