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

Phase 2

• Conditions: Preterm Labor
• Interventions: Drug: Montelukast; Drug: Placebo; Other: urine and vaginal secretions sampling

• Registration Number: NCT02108886
• Lead Sponsor: Université de Sherbrooke

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Primary Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-04
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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
• lupus
• gestational diabetes
• nephropathy
• congenital heart disease
• obvious causes of infection associated with prematurity
• patients with viral infections (HIV, hepatitis)
• patients already treated with Montelukast

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	urine and vaginal secretions sampling	Placebo
Montelukast	Montelukast	Intervention group
Montelukast	urine and vaginal secretions sampling	Intervention group
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time between beginning of treatment and delivery	until delivery (max 17 weeks)

Secondary Outcome Measures

Name	Time	Method
chorio decidual infection	between inclusion and delivery (max 17 weeks)
preterm birth	until delivery (max 13 weeks)	birth before 37 weeks of gestation

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada