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

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ClinicalTrials.gov Identifier: NCT00331695
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: 17 alpha-hydroxyprogesterones caproate Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Study Start Date : June 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
17 alpha-hydroxyprogesterones caproate
Drug: 17 alpha-hydroxyprogesterones caproate
17 alpha-hydroxyprogesterones caproate




Primary Outcome Measures :
  1. Interval between inclusion and delivery. [ Time Frame: during de study ]
    Interval between inclusion and delivery.


Secondary Outcome Measures :
  1. Preterm delivery rate < 37 W, < 34 W et < 32 W, [ Time Frame: during the study ]
    Preterm delivery rate < 37 W, < 34 W et < 32 W,

  2. Number of hospitalizations for preterm labor, [ Time Frame: during the study ]
    Number of hospitalizations for preterm labor,

  3. Cerclage performed at or after 20 weeks, [ Time Frame: during the study ]
    Cerclage performed at or after 20 weeks,

  4. Neonatal weight, [ Time Frame: during the study ]
    Neonatal weight,

  5. NICU transport [ Time Frame: during the study ]
    NICU transport

  6. Respiratory distress syndrome, [ Time Frame: during the study ]
    Respiratory distress syndrome,

  7. Bronchopulmonary dysplasia, [ Time Frame: during the study ]
    Bronchopulmonary dysplasia,

  8. Necrotizing enterocolitis, [ Time Frame: during the study ]
    Necrotizing enterocolitis,

  9. leucomalacia, [ Time Frame: during the study ]
    leucomalacia,

  10. neonatal death. [ Time Frame: during the study ]
    neonatal death.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331695


Locations
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France
CHI Poissy st Germain
Poissy, France, 78303
Chi Poissy St Germain
Poissy, France, 78
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Patrick ROZENBERG, MD, Assistance Publique - Hôpitaux de Paris

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christophe AUCAN, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00331695     History of Changes
Other Study ID Numbers: P040438
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Progesterone
Preterm delivery
Preterm labor
Cervical length
ultrasonography

Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones