Vaginal Indomethacin Versus Oral Nifedipine for Preterm Labor; a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Gestational age
研究概览
简要总结
Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational age neonates.
Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment.
Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive.
Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local administration of Indometacin may be more effective than other forms of administration, as been shown in a previous study.
In this study we aim to compare vaginal Indometacin administration to a commonly used tocolytic agent, nifedipine.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Caregivers will receive a closed envelope with the drug to be used. since the routes of administration are different, from that point on the caregiver and patient will be aware of chosen drug
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singe fetus
- •Gestational age between 24+0/7 and 31+6/7
- •At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
- •Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less
排除标准
- •Rupture of membranes
- •Vaginal bleeding
- •Cervical dilation ≥5cm
- •Known fetal malformations
- •Fetal heart rate abnormalities
- •Suspected placental abruption of adherent placental syndrome
- •Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
- •Maternal hypotension and known aortic or mitral stenosis
- •Presence of cervical cerclage
- •Previous administration of tocolytic drugs in current pregnancy
研究组 & 干预措施
Indomethacin group
Group of patients receiving Indomethacin for preterm labor treatment.
干预措施: Indomethacin (Drug)
Nifedipine group
Group of patients receiving Nifedipine for preterm labor treatment.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Gestational age
时间窗: through study completion, approximately 1 year
Days from last menstrual period
Time to delivery
时间窗: through study completion, approximately 1 year
The time from administration of intervention do delivery
次要结局
- Neonatal birth weight(through study completion, approximately 1 year)
- Rate of extreme preterm deliveries(through study completion, approximately 1 year)
- Neonatal outcomes(through study completion, approximately 1 year)
- Rate of preterm deliveries(through study completion, approximately 1 year)
- neonatal immediate outcomes(through study completion, approximately 1 year)
- Rate of remote from term deliveries(through study completion, approximately 1 year)
- Neonatal immediate outcome(through study completion, approximately 1 year)
研究者
Hila Hocler MD
Principal Investigator
Hadassah Medical Organization