A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- Treatment success rate
研究概览
简要总结
The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
详细描述
There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely.
Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol.
The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy.
- •Aged 20 years or older.
- •At term (37 to 42 weeks inclusive gestation).
- •Cephalic presentation (normal lie).
- •No rupture.
- •Bishop score ≤
- •With an indication for labour induction.
- •Written informed consent.
排除标准
- •Any contraindication to vaginal delivery.
- •Previous of uterine scar(Cesarean section or other uterine surgeries).
- •Heavy or repeated vaginal bleeding in third trimester of pregnancy.
- •Have a history of glaucoma,asthma or epilepsy.
- •Contraindication to prostaglandin use.
- •Known severe allergy to prostaglandin.
- •Placenta previa
- •Premature rupture of membranes
- •Placental abruption
- •Fetal malpresentation(Breech or Transverse)
- •Obvious cephalopelvic disproportion
- •Amniotic Fluid Index more than 250mm or less than 50mm
- •Fetal growth restriction
- •Fetal malformation
- •Fetal distress
- •Preeclampsia or eclampsia
- •Fetal macrosomia of prenatal diagnosis(B-type ultrasonic inspection/Abdomen estimates)
- •Intrahepatic cholestasis syndrome(ICP)
- •Pregnancy with severe heart, lung, liver, kidney, endocrine disease and immune dysfunction
- •Pregnancy with acute systemic infection
- •Pregnancy with Severe anemia
- •Cervical carcinoma
- •Some genital tract infection disease, such as active herpes infection
- •Take part in other clinical trials within three months.
- •The person that investigator thought not be enrolled.
研究组 & 干预措施
Misoprostol Vagianl Tablet
Misoprostol Vaginal Tablet 25 mcg.
干预措施: Misoprostol vaginal Tablet 25 mcg (Drug)
Placebo
Tablet without active ingredient
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment success rate
时间窗: From the first dose to 12-24 hours
Treatment success is defined as: ≧3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours.
次要结局
- Percentage of participants of labor onset within 24 hours(From the first dose to 24 hours)
- Time from 1st dose to labor onset(From the first dose to labor onset)
- Need for augmentation of labor with oxytocin(From the first dose to neonate delivery)
- Rate and reason for Cesarean Section(From the first dose to neonate delivery)