A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 657
- 试验地点
- 14
- 主要终点
- Number of Participants Delivering Before 37 Weeks Gestation
研究概览
简要总结
The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.
详细描述
Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?
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
- Double (Participant, Care Provider)
盲法说明
Patients and care providers are masked to treatment assignment.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous
- •Cervical length as measured on transvaginal examination < 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
- •Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization
排除标准
- •Multifetal gestation
- •Progesterone treatment after 14 weeks 6 days during current pregnancy
- •Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
- •Amniotic membranes prolapsed beyond external os
- •Preterm rupture of membranes
- •Fetal anomaly
- •Pregnancy without a viable fetus
- •Current or planned cervical cerclage
- •Congenital Mullerian abnormality of the uterus
- •Contraindication to intra-muscular injections
- •Hypertension requiring medication
- •Diabetes managed with insulin or oral hypoglycemic agents
- •DES exposure
- •Cervical surgery such as cold knife conization
- •Planned indicated preterm delivery
- •Participation in another interventional study that influences age at delivery
- •Participation in this trial in a previous pregnancy
- •Prenatal care or delivery planned outside a MFMU Network center
研究组 & 干预措施
17 alpha-hydroxyprogesterone caproate
250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
干预措施: 17 alpha-hydroxyprogesterone caproate (Drug)
Placebo
Placebo oil given by weekly injection until 37 weeks gestation or delivery.
干预措施: Placebo Oil (Other)
结局指标
主要结局
Number of Participants Delivering Before 37 Weeks Gestation
时间窗: Delivery before 37 weeks gestation
Number of participants delivering before 37 weeks gestation by indication
次要结局
- Mean Gestational Age at Delivery(Delivery)
- Number of Participants With Gestational Diabetes Mellitus(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Who Had a Cerclage Placement(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Experiencing Gestational Hypertension or Preeclampsia(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Who Delivered Before 28 Weeks Gestation(Delivery)
- Number of Participants With Preterm Premature Rupture of Membranes(<37 weeks)
- Number of Participants Who Delivered Before 35 Weeks Gestation(Delivery)
- Number of Participants Who Delivered Before 32 Weeks Gestation(Delivery)
- Number of Participants Who Visited the Hospital Due to Preterm Labor(Between randomization and 37 weeks gestation)
- Number of Participants Who Underwent Tocolytic Therapy(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Who Underwent Corticosteroid Therapy(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Experiencing Cholestasis(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Who Experienced Placental Abruption(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Who Had Cesarean Delivery(delivery)
- Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components(within 72 hours of delivery)
- Mean Birth Weight(Delivery)
- Birth Weight by Count of Participants(Delivery)
- Number of Neonates Who Measured Small for Gestational Age(Delivery)
- Number of Neonates With a Major Congenital Anomaly(Delivery)
- Number of Participants Who Experienced Chorioamnionitis(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants Who Reported Side Effects(Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks)
- Number of Participants With Apgar Score of Less Than 7 at 5 Minutes(5 minutes post delivery)
- Number of Neonates With Patent Ductus Arteriosus(Delivery through neonatal discharge)
- Number of Neonates Experiencing Seizures(Delivery through neonatal discharge)
- Number of Neonates Admitted to NICU(Delivery through hospital discharge)
- Median Length of NICU Stay(NICU admission through NICU discharge)