Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Condition: Preterm Delivery
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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
    

Intervention name(s): 17 alpha-hydroxyprogesterones caproate
Intervention type(s): Drug
Intervention description(s): 17 alpha-hydroxyprogesterones caproate
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progesterone; Preterm delivery; Preterm labor; Cervical length; ultrasonography