Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 677
- 试验地点
- 17
- 主要终点
- The incidence of delivery < 34 weeks, in the study group versus the control group
研究概览
简要总结
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.
详细描述
Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. Due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever. If markers of preterm delivery can be identified and means of preventing preterm delivery are found, it will be possible to reduce the number of children admitted to hospital because of prematurity.
Recently, two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm. They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group.
The study will be performed as a randomized, double-blind placebo controlled study of twin pregnancies in Denmark and Austria. The women will be randomised in a 1:1 ratio to two groups (progesterone versus placebo). Randomisation will be stratified per centre and according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Twin pregnancy
- •Informed consent
- •18-23 weeks' gestation
- •Participants must be fluent in the language spoken in the respective centres
排除标准
- •Age < 18 years
- •Known allergy to progesterone or peanuts
- •Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
- •Rupture of membranes at the time of inclusion
- •Monoamniotic twins
- •Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
- •Multiple pregnancies reduced to twin pregnancies
- •Known significant structural or chromosomal fetal abnormality
- •Chorionicity not assessed before 15 weeks
- •Known or suspected malignancy in genitals or breasts
- •Known liver disease
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Progesterone
干预措施: Progesterone (Drug)
结局指标
主要结局
The incidence of delivery < 34 weeks, in the study group versus the control group
时间窗: Participants will be followed until 3 weeks after delivery
次要结局
- Physical and neurological development of the children at 6 and 18 months(2 years after delivery)
- The relationship between cervical length and prophylactic progesterone treatment(Participants will be followed until 3 weeks after delivery)
- Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA(Participants will be followed until 3 weeks after delivery)
- Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements(Participants will be followed until 3 weeks after delivery)
- Assessment of the effect of progesterone on CRH-levels in twin pregnancies(Participants will be followed until 3 weeks after delivery)