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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Preterm Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Montelukast

Intervention group

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.

urine and vaginal secretions sampling

Intervention Type OTHER

Urine and vaginal secretions sampling, once a week in both groups

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

empty capsule filled with sugar

urine and vaginal secretions sampling

Intervention Type OTHER

Urine and vaginal secretions sampling, once a week in both groups

Interventions

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Montelukast

10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.

Intervention Type DRUG

Placebo

empty capsule filled with sugar

Intervention Type DRUG

urine and vaginal secretions sampling

Urine and vaginal secretions sampling, once a week in both groups

Intervention Type OTHER

Other Intervention Names

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Singulair

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No