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

NCT02108886 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-03-04

No results posted yet for this study

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.

Conditions

  • Preterm Labor

Interventions

DRUG

Montelukast

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

DRUG

Placebo

empty capsule filled with sugar

OTHER

urine and vaginal secretions sampling

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

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Jean-Charles Pasquier, MD, PhD · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-07-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02108886 on ClinicalTrials.gov