NCT02108886

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

January 15, 2013

Last Update Submit

March 3, 2015

Conditions

Preterm Labor

Keywords

preterm labormontelukastuterine contractions

Outcome Measures

Primary Outcomes (1)

  • Time between beginning of treatment and delivery

    until delivery (max 17 weeks)

Secondary Outcomes (2)

  • preterm birth

    until delivery (max 13 weeks)

  • chorio decidual infection

    between inclusion and delivery (max 17 weeks)

Study Arms (2)

Montelukast

EXPERIMENTAL

Intervention group

Drug: MontelukastOther: urine and vaginal secretions sampling

Placebo

PLACEBO COMPARATOR

Placebo

Drug: PlaceboOther: urine and vaginal secretions sampling

Interventions

MontelukastDRUG

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

Also known as: Singulair
Montelukast
PlaceboDRUG

empty capsule filled with sugar

Placebo
urine and vaginal secretions samplingOTHER

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

MontelukastPlacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with 24-34 weeks of pregnancy
  • indication for tocolysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

montelukastUrination

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Jean-Charles Pasquier, MD, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2013

First Posted

April 9, 2014

Study Start

December 1, 2011

Primary Completion

July 1, 2014

Study Completion

December 1, 2015

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

CA(1)