NCT04748562已完成4 期
Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Preterm labor
研究概览
简要总结
It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy.
There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravidae
- •Twin pregnancies at gestational age 14 week.
- •Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.)
排除标准
- •Polyhydramnios
- •Twins with congenital malformation
- •Twin to twin transfusion
- •Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis
- •Previous cervical surgery
- •High order pregnancy (triples or more)
研究组 & 干预措施
400 mg progesterone group
Active Comparator
Taking 400 mg vaginal progesterone
干预措施: Progesterone (Drug)
200 mg progesterone group
Active Comparator
Taking 200 mg vaginal progesterone
干预措施: Progesterone (Drug)
结局指标
主要结局
Preterm labor
时间窗: Before 37 weeks gestation
Number of participants which had preterm labor
次要结局
- Cervical length changes(Between 14 weeks and 22 weeks gestation)
- Neonatal ICU admission(The first 28 days after delivery)
- Neonatal mechanical ventilation(The first 28 days after delivery)
- Progesterone side effects(During one year which is the period from the start of the study till its end)
研究者
研究点 (1)
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