Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
Overview
- Phase
- Phase 2
- Intervention
- urine and vaginal secretions sampling
- Conditions
- Preterm Labor
- Sponsor
- Université de Sherbrooke
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Time between beginning of treatment and delivery
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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. Cervical secretions and urine will be sample at the admission, after one week and every two weeks during treatment.
Investigators
Jean-Charles Pasquier, MD, PhD
Dr
Université de Sherbrooke
Eligibility Criteria
Inclusion Criteria
- •women with 24-34 weeks of pregnancy
- •indication for tocolysis
Exclusion Criteria
- •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
Arms & Interventions
Montelukast
Intervention group
Intervention: urine and vaginal secretions sampling
Montelukast
Intervention group
Intervention: Montelukast
Placebo
Placebo
Intervention: Placebo
Placebo
Placebo
Intervention: urine and vaginal secretions sampling
Outcomes
Primary Outcomes
Time between beginning of treatment and delivery
Time Frame: until delivery (max 17 weeks)
Secondary Outcomes
- preterm birth(until delivery (max 13 weeks))
- chorio decidual infection(between inclusion and delivery (max 17 weeks))