Overview

This trial is active, not recruiting.

Condition preterm labor
Treatments montelukast, placebo, urine and vaginal secretions sampling
Phase phase 2
Sponsor Université de Sherbrooke
Start date December 2011
End date July 2014
Trial size 100 participants
Trial identifier NCT02108886, 11-143

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Intervention group
montelukast Singulair
10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
urine and vaginal secretions sampling
Urine and vaginal secretions sampling, once a week in both groups
(Placebo Comparator)
Placebo
placebo
empty capsule filled with sugar
urine and vaginal secretions sampling
Urine and vaginal secretions sampling, once a week in both groups

Primary Outcomes

Measure
Time between beginning of treatment and delivery
time frame: until delivery (max 17 weeks)

Secondary Outcomes

Measure
preterm birth
time frame: until delivery (max 13 weeks)
chorio decidual infection
time frame: between inclusion and delivery (max 17 weeks)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
Principal investigator Jean-Charles Pasquier, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.