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

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: Preterm Labor
• Intervention / Treatment: Drug: Montelukast; Other: urine and vaginal secretions sampling; Drug: Placebo

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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)

Collaborators and Investigators

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

Study record dates

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: preterm labor; montelukast; uterine contractions
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 11-143