Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- delivery within 48 hours
研究概览
简要总结
Indomethacin for tocolysis for 48 hours vs placebo
详细描述
Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy.
Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preterm labor as defined by regular uterine contractions (at least 6/hour) with cervical change of at least 1 cm or cervical shortening on transvaginal ultrasound less than 25mm of functional length
- •Gestational age 23w0d to 31w6d weeks
- •Singleton
- •≥ 18 years old
- •Able to consent in English
排除标准
- •Major congenital anomalies associated with an increased risk of newborn death
- •Multiple fetal gestation (2+)
- •Known intrauterine fetal demise
- •Non-reassuring fetal status requiring delivery
- •Preterm premature rupture of membranes (PPROM)
- •Suspected or known intrauterine infection
- •Placenta previa
- •Maternal allergy or contraindication to indomethacin (peptic ulcer disease, thrombocytopenia, coagulopathy, renal or hepatic dysfunction)
- •Inevitable delivery (cervix ≥6cm dilated)
研究组 & 干预措施
Placebo
The patient will be given a loading dose of 50mg placebo by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours.
干预措施: Placebo (Drug)
Indomethacin
The patient will be given a loading dose of 50mg indomethacin by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours.
干预措施: Indomethacin (Drug)
结局指标
主要结局
delivery within 48 hours
时间窗: 48 hours after enrollment
The percentage of patients remaining undelivered after 48 hours
次要结局
- delivery within 7 days(7 days after enrollment)
- delivery before 37 weeks(participants will be followed for the duration of pregnancy through their postpartum period, an expected time of up to 20 weeks)
- Maternal and Fetal Complications(participants will be followed for the duration of pregnancy through their postpartum period and neonatal hospital stay, an expected time of up to 24 weeks)
研究者
Kelly S Gibson
Maternal Fetal Medicine
MetroHealth Medical Center