NCT03343795已完成4 期
Oral Versus Parental Progesterone in the Management of Preterm Labor
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
- 80
- 试验地点
- 1
- 主要终点
- the rate of preterm labor
研究概览
简要总结
Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately 12% of pregnancies in the United States
Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Past history of one or more spontaneous preterm labor.
- •Singleton pregnancy.
- •Pregnancy of less than 20 weeks of gestation
排除标准
- •Women on tocolytic drugs .
- •Underwent cervical cerclage in this pregnancy .
- •Multiple gestations .
- •Major fetal congenital malformations .
- •Pregnancy 0f more than 20 weeks gestation .
研究组 & 干预措施
study group 1
Experimental
oral progesterone
干预措施: oral progesterone (Drug)
study group 2
Active Comparator
intramuscular progesterone
干预措施: intramuscular progesterone (Drug)
结局指标
主要结局
the rate of preterm labor
时间窗: 10 weeks
number of women delivered before 37 weeks
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University
研究点 (1)
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