Preterm Labor Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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