Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Preterm Birth <37 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.
详细描述
Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with singleton pregnancies
- •≥18 years old
- •Estimated gestational age less than 24 0/7 weeks
- •Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.
- •Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
排除标准
- •History of an adverse reaction to progesterone;
- •A contraindication to progesterone treatment;
- •Placenta previa or accreta;
- •Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;
- •Multifetal gestation;
- •Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment
研究组 & 干预措施
Vaginal Progesterone
200mg micronized progesterone vaginally, to be taken daily starting at 16 0/7 - 23 6/7 weeks, and continued daily until 36 6/7 weeks' gestation or delivery
干预措施: Vaginal Progesterone (Drug)
Intramuscular Progesterone
250mg intramuscular progesterone to be administered weekly starting at 16 0/7 - 23 6/7 weeks, and continued weekly until 36 6/7 weeks' or delivery.
干预措施: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) (Drug)
结局指标
主要结局
Preterm Birth <37 Weeks
时间窗: up to 9 months (delivery)
Incidence of gestational age of delivery less than 37 weeks
次要结局
- Birthweight(up to 9 months (delivery))
- Gestational Age of Delivery(up to 9 months (delivery))
- Preterm Birth <34 Weeks(up to 9 months (delivery))
- Second Trimester Cervical Length <25mm(2 months)
- Mode of Delivery: Cesarean Section(up to 9 months (delivery))
- Maternal Mortality(up to 9 months (delivery))
- 5 Minute Apgar Score<7(up to 9 months (delivery))
- Neonatal Intensive Care Unit Admission(up to 9 months (delivery))
- Composite Neonatal Morbidity(up to 9 months (delivery))
- Perinatal Mortality up to 28 Days of Life(up to 10 months (4 weeks after delivery))
- Medication Side Effects(up to 9 months (delivery))
- Satisfaction With Medication (5 Point Likert Scale)(up to 9 months (delivery))
- Medication Adherence(up to 9 months (delivery))
- Planned Subgroup Analysis for the Outcome Preterm Birth <37 Weeks, <34 Weeks, <28 Weeks(up to 9 months (delivery))