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临床试验/EUCTR2016-000147-13-FR
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

发起方
CHU de LIMOGES

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