Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Participants Who Delivered Before 37 Weeks'
研究概览
简要总结
Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.
详细描述
RESEARCH DESIGN AND METHODS
The investigators will perform a randomized, blinded, placebo-controlled trial to evaluate the use of vaginal progesterone in women with arrested preterm labor after 24 weeks' gestation to reduce the risk of preterm birth before 37 weeks' gestation. Women enrolled in the study will be randomized to daily vaginal administration of progesterone (200 mg) or placebo from time of enrollment until 36 6/7 weeks' gestation. Women will be eligible if they have a singleton or twin gestation between 24 0/7 and 33 6/7 weeks' gestation and initially present with regular uterine contractions and a clinical diagnosis of preterm labor but remain undelivered without further cervical change 12 hours after discontinuation of acute tocolytic therapy. Women may also participate if it has been less than if they are considered eligible for discharge based on attending physician judgement prior to the 12 hour period of time.
Randomization and Blinding- Participants in the study will be randomized using a computer-generated randomization scheme with 1:1 allocation to receive progesterone or placebo. Investigators and research team members, participants, and the obstetric providers will be blinded to the allocated intervention.
Procedures-
- Data collection- Information will be recorded from the participant's medical record. Additional study information not included in the medical record will be obtained directly from the participant in an interview with the research team member.
- Follow-up- Regardless of whether the participant remains hospitalized or is discharged prior to delivery, she will meet with a study coordinator every 2 weeks. During the follow-up visit, a study team member will discuss compliance with the study drug and possible side effects. The participant will fill out a 1-page questionnaire that asks questions about compliance and side effects. This information will be recorded and provided to the Data Safety and Monitoring Board at the midpoint review.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton or twin gestation
- •Estimated gestational age between 24 0/7 and 33 6/7 weeks' gestation
- •Initially present with regular contractions and clinical diagnosis of preterm labor but remain undelivered with 1) no further cervical change 12 hours after discontinuation of acute tocolytic therapy; or 2) be considered eligible for discharge based on attending physician judgment prior to the 12 hour period of time
- •The participant's cervix must be at least 1 cm at the time of enrollment
排除标准
- •Non-English speaking
- •Rupture of membranes
- •Chorioamnionitis
- •Non-reassuring fetal status
- •Maternal indication for delivery
- •Placental abruption
- •Intrauterine fetal demise
- •Prenatally diagnosed major fetal anomaly
- •Cervical cerclage in place
- •Previous administration of progesterone during the current pregnancy for a history of preterm birth or short cervix
- •Participant is either unwilling or unable to attend follow-up study visits following hospital discharge
研究组 & 干预措施
Micronized progesterone suppository
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
干预措施: Micronized progesterone suppository (Drug)
Placebo suppository
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
干预措施: Micronized progesterone suppository (Drug)
结局指标
主要结局
Number of Participants Who Delivered Before 37 Weeks'
时间窗: Duration of current pregnancy, anticipated maximum 18 weeks
次要结局
- Number of Participants Who Delivered Before 34 Weeks'(Duration of current pregnancy, anticipated maximum 18 weeks)
- Delivery Within 2 Weeks of Randomization(2 weeks)
- Number of Weeks Pregnancy Prolongation(Duration of current pregnancy, anticipated maximum 18 weeks)
- Number of Participants With Chorioamnionitis(Duration of current pregnancy, anticipated maximum 18 weeks)
- Composite Neonatal Outcome(Followed for duration of neonatal hospital stay, estimated maximum 16 weeks)
- Infant Birth Weight(Day of delivery in current pregnancy)
- Neonatal Intensive Care Unit Admission(Followed for duration of neonatal hospital stay, estimated maximum 16 weeks)