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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Labor

Intervention / Treatment
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* Drug: Montelukast
* Drug: Placebo
* Other: urine and vaginal secretions sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast<br>Intervention group | Drug: Montelukast<br>* 10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.<br>* Other names: Singulair;Other: urine and vaginal secretions sampling<br>* Urine and vaginal secretions sampling, once a week in both groups<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* empty capsule filled with sugar<br>Other: urine and vaginal secretions sampling<br>* Urine and vaginal secretions sampling, once a week in both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between beginning of treatment and delivery |  | until delivery (max 17 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth | birth before 37 weeks of gestation | until delivery (max 13 weeks) | 
| chorio decidual infection |  | between inclusion and delivery (max 17 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm labor, montelukast, uterine contractions