Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of preterm birth (before 37 weeks of gestation)
研究概览
简要总结
The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.
详细描述
Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between 26 and 34 weeks of gestation.
- •Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.
排除标准
- •Multiple gestations.
- •Maternal pathologies in which preterm termination of pregnancy is required.
研究组 & 干预措施
17 α hydroxyprogesterone caproate
17α-Hydroxyprogesterone caproate.
干预措施: 17 α hydroxyprogesterone caproate (Drug)
Placebo
Saline solution.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of preterm birth (before 37 weeks of gestation)
时间窗: 18 months
Number of patients that delivered before 37 weeks of pregnancy
次要结局
- Incidence of preterm birth before 32 weeks of pregnancy(18 months)
- Incidence of preterm birth before 35 weeks of pregnancy(18 months)
研究者
Osvaldo A. Reyes T.
MD
Saint Thomas Hospital, Panama