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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00331695 |
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:
Condition | Intervention | Phase |
---|---|---|
Preterm Delivery Risk |
Drug: 17 alpha-hydroxyprogesterones caproate |
Phase IV |
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 |
Estimated Enrollment: | 560 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2008 |
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:
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
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrick ROZENBERG, MD | +33 1 39 27 52 57 | prozenberg@chi-poissy-st-germain.fr |
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 |
Principal Investigator: | Patrick ROZENBERG, MD, | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P040438, AOM 04038 |
Study First Received: | May 30, 2006 |
Last Updated: | March 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00331695 |
Health Authority: | France: Ministry of Health |
Progesterone Preterm delivery Preterm labor Cervical length ultrasonography |
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 |
Estrogen Receptor Modulators Estrogen Antagonists Hormone Antagonists Progestins Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Estradiol Antagonists Pharmacologic Actions |