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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPreterm Labor
InterventionDrug: Montelukast
Drug: Placebo
Other: urine and vaginal secretions sampling
PhasePhase 2
SponsorUniversité de Sherbrooke
Responsible PartyUniversité de Sherbrooke
ClinicalTrials.gov IdentifierNCT02108886
First ReceivedJanuary 15, 2013
Last UpdatedApril 4, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateJanuary 15, 2013
Last Updated DateApril 4, 2014
Start DateDecember 2011
Estimated Primary Completion DateDecember 2014
Current Primary Outcome MeasuresTime between beginning of treatment and delivery [Time Frame: until delivery (max 17 weeks)] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • preterm birth [Time Frame: until delivery (max 13 weeks)] [Designated as safety issue: No]birth before 37 weeks of gestation
  • chorio decidual infection [Time Frame: between inclusion and delivery (max 17 weeks)] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitlePilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth
Official TitlePilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth.
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.
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 TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
ConditionPreterm Labor
InterventionDrug: Montelukast
10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
Other Names:
SingulairDrug: Placebo
empty capsule filled with sugar
Other: urine and vaginal secretions sampling
Urine and vaginal secretions sampling, once a week in both groups
Study Arm (s)
  • Experimental: Montelukast
    Intervention group
  • Placebo Comparator: Placebo
    Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment100
Estimated Completion DateDecember 2014
Estimated Primary Completion DateJuly 2014
Eligibility 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Simon Blouin, PhD
819-346-1110
syblouin.chus@ssss.gouv.qc.ca
Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT02108886
Other Study ID Numbers11-143
Has Data Monitoring CommitteeNo
Information Provided ByUniversité de Sherbrooke
Study SponsorUniversité de Sherbrooke
CollaboratorsNot Provided
Investigators Principal Investigator: Jean-Charles Pasquier, MD, PhD Université de Sherbrooke
Verification DateApril 2014

Locations[ + expand ][ + ]

Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Simon Blouin, PhD | 819-346-111013877 | syblouin.chus@ssss.gouv.qc.ca
Principal Investigator: Jean-Charles Pasquier, MD, PhD
Recruiting