Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Study Overview
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Brief Summary
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The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

Detailed Description
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The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.

Official Title
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Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

Conditions
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Preterm Delivery, Morbidity, Perinatal Mortality

Intervention / Treatment
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* Drug: progesterone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks) Singleton pregnancy Intact membranes Preterm labor defined as: 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria: short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks) cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6 cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams) positive fetal fibronectin Age ≥ 18 years old Signed informed consent Possible and accepted follow-up Exclusion Criteria: Multiple gestation Cervical cerclage Hydramnios (AFI >95th percentile for gestational age or greatest pocket >8 cm) Premature rupture of membranes Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor) Cervical dilatation > 3 cm Placenta praevia or abruptio placentae Intra-uterine growth restriction or non-reassuring fetal status Pre-eclampsia or severe hypertension Any other maternal or fetal pathology which should indicate medically preterm delivery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: progesterone<br>* vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).<br>* Other names: Utrogestan;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation |  | end of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects |  | end of pregnancy and 28 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm delivery, preterm labor, perinatal morbidity, perinatal mortality