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

Information source: Université de Sherbrooke
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Labor

Intervention: Montelukast (Drug); Placebo (Drug); urine and vaginal secretions sampling (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Université de Sherbrooke

Official(s) and/or principal investigator(s):
Jean-Charles Pasquier, MD, PhD, Principal Investigator, Affiliation: Université de Sherbrooke

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time between beginning of treatment and delivery

Secondary outcome:

preterm birth

chorio decidual infection

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec J1H 5N4, Canada
Additional Information

Starting date: December 2011
Last updated: March 3, 2015

Page last updated: August 23, 2015

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