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

Preterm Labor Clinical Trial

— EAU2-Mtlk  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02108886
• Other study ID #: 11-143
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 15, 2013
• Last updated: March 3, 2015
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• Montelukast
10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
• Placebo
empty capsule filled with sugar

Other:
• urine and vaginal secretions sampling
Urine and vaginal secretions sampling, once a week in both groups

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between beginning of treatment and delivery		until delivery (max 17 weeks)	No
Secondary	preterm birth	birth before 37 weeks of gestation	until delivery (max 13 weeks)	No
Secondary	chorio decidual infection		between inclusion and delivery (max 17 weeks)	No