Preterm Labor
Conditions
Keywords
preterm labor, montelukast, uterine contractions
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.
Interventions
DRUGMontelukast
10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
DRUGPlacebo
empty capsule filled with sugar
OTHERurine and vaginal secretions sampling
Urine and vaginal secretions sampling, once a week in both groups
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time between beginning of treatment and delivery | until delivery (max 17 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| preterm birth | until delivery (max 13 weeks) | birth before 37 weeks of gestation |
| chorio decidual infection | between inclusion and delivery (max 17 weeks) | — |
Countries
Canada
Outcome results
None listed