Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- comparing the duration of induction-to-vaginal delivery
研究概览
简要总结
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB).
The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously.
The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at term (37 weeks of gestation or more) with singleton
- •pregnancies that are intended for IOL.
- •Initial bishop score <5
- •No contraindications to receive either treatment.
- •Women who will give informed consent to be included in the study.
- •Women at or over the age of 18.
排除标准
- •Women with a known hypersensitivity or contraindications to Propess / PGE
- •Parity 5 or more
- •Labor contractions more than 4 in 20 min
- •History of previous uterine surgery
- •Hypersensitivity to prostaglandins
- •Vaginal delivery is contraindicated
- •Active cardiac, renal, pulmonary, or hepatic disease
- •Severe asthma or pulmonary disease
研究组 & 干预措施
Propess pessary
Placement of a slow-release 10 mg dinoprostone insert (propess) in the posterior fornix for up to 24 hours until labor initiation or favorable cervix, followed by amniotomy and oxytocin administration. In a case of failure, induction of labor will be done with either PGE2 gel and/or Foley catheter.
干预措施: Dinoprostone vaginal insert (Drug)
Sequential PGE2 vaginal gel and Foley catheter balloon
Insertion of 1 mg dinoprostone (PGE2) vaginal gel to the posterior fornix with reassessment up to 6 hours later. If the Bishop score is still less than 5 and there are no more than 4 contractions in 20 minutes of monitoring, an additional PGE2 vaginal gel of 2 mg is inserted. If there are more than 4 contractions in 20 minutes of monitoring or if after up to 6 hours there will be low Bishop score, a 60 ml Foley catheter balloon is placed for 6 to 12 hours or until spontaneous expulsion. When the cervix is favorable, amniotomy and oxytocin administration are followed.
In a case of a failure, induction of labor with Propess will be conducted.
干预措施: Dinoprostone gel and Foley catheter balloon (Combination Product)
结局指标
主要结局
comparing the duration of induction-to-vaginal delivery
时间窗: from enrollment until final outcome - a month
measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery.
次要结局
- rate of vaginal delivery in 24 and 48 hours from IOL(from enrollment until final outcome - a month)
- Number of Participants with Treatment-Related Adverse Events(from enrollment until final outcome - a month)
- rate of Induction success(from enrollment until final outcome - a month)
- rate o Cervical ripening success(from enrollment until final outcome - a month)
研究者
Zohar Nachum
professor
HaEmek Medical Center, Israel