NCT02108886

Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth

Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DRUG	Montelukast	10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
DRUG	Placebo	empty capsule filled with sugar
OTHER	urine and vaginal secretions sampling	Urine and vaginal secretions sampling, once a week in both groups

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-07-01
• Completion: 2015-12-01
• First posted: 2014-04-09
• Last updated: 2015-03-04

Locations

1 site across 1 country: Canada