Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth (EAU2-Mtlk)

March 3, 2015 updated by: Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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