Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
研究概览
简要总结
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.
Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.
详细描述
Patients presenting between 24-34 weeks gestation diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton and twin gestations
- •Intact amniotic membranes
- •No contra-indications to tocolysis
- •24-34 weeks gestation by last menstrual period and/or ultrasound
- •Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement
排除标准
- •Ruptured amniotic membranes
- •Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
- •Non-reassuring fetal heart rate tracings
- •Contra-indications to indomethacin or nifedipine
- •Contra-indications to tocolysis
研究组 & 干预措施
Indomethacin
50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
干预措施: Indomethacin (Drug)
Nifedipine
30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
时间窗: Two weeks after enrolled and randomized, up to 37 weeks of pregnancy
Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.
次要结局
- Gestational Age at Delivery(Up to 42 weeks of pregnancy)
- Count of Participants With Neonatal Morbidity(Up to 42 weeks of pregnancy)
- Neonatal Birthweight(Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery)
- Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery(Up to 42 weeks of pregnancy)
- Time to Uterine Quiescence(Up to 42 weeks of pregnancy)
- Count of Participants With Side-effect Due to the Medication(Up to 42 weeks of pregnancy)
研究者
Deirdre Judith Lyell
Associate Professor
Stanford University