Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Study Overview
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Brief Summary
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To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and: either a first episode of preterm labor stopped by acute tocolysis; either a history of late miscarriage or premature delivery or uterine malformation or DES either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

Detailed Description
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Objective To demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and: either a first episode of preterm labor stopped by acute tocolysis; either a history of late miscarriage or premature delivery or uterine malformation or DES either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms. The maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation. Arm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group. IM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group. Arm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria nausea,vomiting, weakness

Official Title
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Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Conditions
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Preterm Delivery

Intervention / Treatment
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* Drug: 17 alpha-hydroxyprogesterones caproate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and: either a first episode of preterm labor stopped by acute tocolysis either a history of late miscarriage or premature delivery or uterine malformation or DES; either a twin pregnancy. Exclusion Criteria: cervical dilatation > 3 cm, chorioamnionitis, fetal distress, placenta praevia, abruptio placenta, preterm premature rupture of membranes, polyhydramnios, Twin-twin transfusion syndrome, IUGR, preeclampsia or hypertension, other pathology justifying a preterm delivery, epilepsy drugs participation to another therapeutic trial, any patient for whom informed consent cannot be obtained.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>17 alpha-hydroxyprogesterones caproate | Drug: 17 alpha-hydroxyprogesterones caproate<br>* 17 alpha-hydroxyprogesterones caproate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interval between inclusion and delivery. | Interval between inclusion and delivery. | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery rate < 37 W, < 34 W et < 32 W, | Preterm delivery rate < 37 W, < 34 W et < 32 W, | during the study | 
| Number of hospitalizations for preterm labor, | Number of hospitalizations for preterm labor, | during the study | 
| Cerclage performed at or after 20 weeks, | Cerclage performed at or after 20 weeks, | during the study | 
| Neonatal weight, | Neonatal weight, | during the study | 
| NICU transport | NICU transport | during the study | 
| Respiratory distress syndrome, | Respiratory distress syndrome, | during the study | 
| Bronchopulmonary dysplasia, | Bronchopulmonary dysplasia, | during the study | 
| Necrotizing enterocolitis, | Necrotizing enterocolitis, | during the study | 
| leucomalacia, | leucomalacia, | during the study | 
| neonatal death. | neonatal death. | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progesterone, Preterm delivery, Preterm labor, Cervical length, ultrasonography