EUCTR2016-000147-13-FR进行中(未招募)1 期
Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term? - RE-DINO
CHU de LIMOGES0 个研究点目标入组 360 人开始时间: 2016年4月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Age = 18 years.
- •- Term pregnancy> 37 weeks
- •- Current Trigger medically indicated
- •- Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
- •- Cephalic presentation
- •- Unfavorable cervical conditions (Bishop score <6), one hour before inclusion
- •- Intact membranes
- •- Affiliated with the French social security system
- •- Having signed the consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Multiple pregnancy
- •- Uterus scar
- •- Contraindications to epidural anesthesia
- •- Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins
- •- Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
- •- Contraindications to vaginal delivery
- •- Premature Rupture of Membranes (PROM)
- •- Intra Uterine Growth retardation (IUGR) < 3rd percentile
- •- Macrosomia > 97th percentile
- •- Impaired fetal heart rate
- •- Fetal Death In Utéro (IUFD)
- •- Patient under guardianship, curatorship or safeguard justice
研究者
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