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

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, March 2007

Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00331695
  Purpose

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 Intervention Phase
Preterm Delivery Risk
Drug: 17 alpha-hydroxyprogesterones caproate
Phase IV

ChemIDplus related topics:   Hydroxyprogesterone caproate    17-Hydroxyprogesterone    Progesterone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Evaluation of the Efficacy of 17 Alpha-Hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Interval between inclusion and delivery.

Secondary Outcome Measures:
  • Preterm delivery rate < 37 W, < 34 W et < 32 W,
  • Number of hospitalizations for preterm labor,
  • Cerclage performed at or after 20 weeks,
  • Neonatal weight,
  • NICU transport
  • Respiratory distress syndrome,
  • Bronchopulmonary dysplasia,
  • Necrotizing enterocolitis,
  • leucomalacia,
  • neonatal death.

Estimated Enrollment:   560
Study Start Date:   June 2006
Estimated Study Completion Date:   December 2008

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, multicentre, 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
  Eligibility
Ages Eligible for Study:   18 Years to 49 Years
Genders 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331695

Contacts
Contact: Patrick ROZENBERG, MD     +33 1 39 27 52 57     prozenberg@chi-poissy-st-germain.fr    

Locations
France
Chi Poissy St Germain     Recruiting
      POISSY, France, 78
      Contact: Patrick ROZENBERG, MD     +33 (0)-1 39 27 52 57     prozenberg@chi-poissy-st-germain.fr    
CHI Poissy st Germain     Recruiting
      Poissy, France, 78303
      Contact: Patrick ROZENBERG, MD     +33(0)-1 39 27 56 68     prozenberg@chi-poissy-st-germain.fr    

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Investigators
Principal Investigator:     Patrick ROZENBERG, MD,     Assistance Publique - Hôpitaux de Paris    
  More Information


Publications:

Study ID Numbers:   P040438, AOM 04038
First Received:   May 30, 2006
Last Updated:   March 14, 2007
ClinicalTrials.gov Identifier:   NCT00331695
Health Authority:   France: Ministry of Health

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

Study placed in the following topic categories:
Pregnancy Complications
Progesterone
Estradiol 3-benzoate
Obstetric Labor, Premature
Estradiol valerate
Obstetric Labor Complications
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol
17-alpha-hydroxy-progesterone caproate
Premature Birth

Additional relevant MeSH terms:
Estrogen Receptor Modulators
Estrogen Antagonists
Hormone Antagonists
Progestins
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Estradiol Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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