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. |
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Condition | Preterm Labor |
Intervention | Drug: Montelukast Drug: Placebo Other: urine and vaginal secretions sampling |
Phase | Phase 2 |
Sponsor | Université de Sherbrooke |
Responsible Party | Université de Sherbrooke |
ClinicalTrials.gov Identifier | NCT02108886 |
First Received | January 15, 2013 |
Last Updated | April 4, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 15, 2013 |
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Last Updated Date | April 4, 2014 |
Start Date | December 2011 |
Estimated Primary Completion Date | December 2014 |
Current Primary Outcome Measures | Time between beginning of treatment and delivery [Time Frame: until delivery (max 17 weeks)] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth |
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Official Title | Pilot 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 Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Preterm Labor |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | December 2014 |
Estimated Primary Completion Date | July 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Simon Blouin, PhD 819-346-1110 syblouin.chus@ssss.gouv.qc.ca |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02108886 |
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Other Study ID Numbers | 11-143 |
Has Data Monitoring Committee | No |
Information Provided By | Université de Sherbrooke |
Study Sponsor | Université de Sherbrooke |
Collaborators | Not Provided |
Investigators | Principal Investigator: Jean-Charles Pasquier, MD, PhD Université de Sherbrooke |
Verification Date | April 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.caPrincipal Investigator: Jean-Charles Pasquier, MD, PhD Recruiting |
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