Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- time period between beginning of labor induction to delivery
研究概览
简要总结
This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.
详细描述
This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
two dinoprostone agents are randomly applied and compared - one in patient's cervix and the other in vagina without the patient knowing which agent is applied
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •term pregnancies (> 37 weeks gestation)
- •unfavourable cervix (Bishop score <6)
- •indication for labor induction
- •absence of uterine contractions
- •reassuring cardiotocography
排除标准
- •ruptured membranes
- •scar uterus (previous caesarean section or uterus surgery)
- •pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
研究组 & 干预措施
GROUP A
106 randomly selected pregnant women
干预措施: Dinoprostone 0.5 MG (Drug)
GROUP B
106 randomly selected pregnant women
干预措施: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly (Drug)
结局指标
主要结局
time period between beginning of labor induction to delivery
时间窗: 5 days
hours (difference of 4 hours or more is considered significant)
次要结局
- number of deliveries by caesarean section or instrumental deliveries(7 days)
- number of births within 24h of start of labor induction(7 days)
- number of uterus hyperstimulation(7 days)
研究者
Katja Vince
Principal Investigator
Clinical Hospital Merkur