Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time between beginning of treatment and delivery
研究概览
简要总结
Preterm birth is a major public health problem, and actual treatments are not very efficient. The purpose of this study is to test the efficiency of a combined use of Montelukast and Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more efficiently than with the use of Nifedipine only.
详细描述
An inflammatory process is involved in 60% of preterm births. Moreover, investigators previously demonstrated that enzymes of lipoxygenase pathway are present in uterine smooth muscle, and that an additive tocolytic effect can be obtained from the combined use of Montelukast and Nifedipine.
Methods:
This is a double-blinded randomized controlled assay performed at the CHUS on two groups of 50 women. Women will be selected when admitted for preterm labor with a gestational age between 26 and 34 weeks.
The first group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to 10 mg of Montelukast per day, until delivery or 35 weeks of pregnancy.
The second group will receive Nifedipine for 48 hours, as described by the standard protocol at the CHUS, in addition to a placebo per day, until delivery or 35 weeks of pregnancy.
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
- Triple (Participant, Care Provider, Investigator)
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
- •women with 24-34 weeks of pregnancy
- •indication for tocolysis
排除标准
- •preterm labor before 26 or after 34 weeks of pregnancy
- •minor patients
- •patients with other obstetrical pathology
- •twin pregnancies
- •fetal distress
- •severe congenital fetal malformation
- •anti-phospholipid syndrome
- •gestational diabetes
- •nephropathy
- •congenital heart disease
- •obvious causes of infection associated with prematurity
- •patients with viral infections (HIV, hepatitis)
- •patients already treated with Montelukast
研究组 & 干预措施
Montelukast
Intervention group
干预措施: urine and vaginal secretions sampling (Other)
Montelukast
Intervention group
干预措施: Montelukast (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
Placebo
Placebo
干预措施: urine and vaginal secretions sampling (Other)
结局指标
主要结局
Time between beginning of treatment and delivery
时间窗: until delivery (max 17 weeks)
次要结局
- preterm birth(until delivery (max 13 weeks))
- chorio decidual infection(between inclusion and delivery (max 17 weeks))
研究者
Jean-Charles Pasquier, MD, PhD
Dr
Université de Sherbrooke