Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Preterm Birth
研究概览
简要总结
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.
Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.
详细描述
This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.
Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.
While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies
- •History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)
- •Gestational age between 16 weeks 0 days and 20 weeks 6 days.
- •Signed consent to participate in the trial
排除标准
- •Multiple Gestation
- •Prior elective fetal reduction or planned termination
- •Known spontaneous reduction to singleton
- •Major fetal anomaly or known fetal chromosomal abnormalities
- •Progesteone used this pregnancy
研究组 & 干预措施
Intramuscular Progesterone
Intramuscular Progesterone
干预措施: Intramuscular Progesterone (Drug)
Vaginal Progesterone
Vaginal Progesterone
干预措施: Vaginal Progesterone (Drug)
结局指标
主要结局
Preterm Birth
时间窗: From 16-20 weeks gestation through preterm delivery
Delivery before 37 weeks gestation.
次要结局
- Mean Neonatal Birth Weight(At delivery)
- Gestational Age at Delivery(From 16-20 weeks gestation through preterm delivery)
- Preterm Birth(From 16-20 weeks gestation through preterm delivery)