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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:
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 History of Changes |
Health Authority: | France: Ministry of Health |
Progesterone Preterm delivery Preterm labor Cervical length ultrasonography |
Estrogen Antagonists Estrogens Pregnancy Complications Progesterone Obstetric Labor, Premature Hormone Antagonists Caproate Estradiol valerate Obstetric Labor Complications Hormones, Hormone Substitutes, and Hormone Antagonists |
Estradiol 17 beta-cypionate Hormones Estradiol 17-alpha-hydroxy-progesterone caproate Estrogen Receptor Modulators Progestins Estradiol 3-benzoate Polyestradiol phosphate Premature Birth |
Estrogen Antagonists Pregnancy Complications Hormone Antagonists Obstetric Labor, Premature Physiological Effects of Drugs Obstetric Labor Complications Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones 17-alpha-hydroxy-progesterone caproate Pharmacologic Actions Estrogen Receptor Modulators Progestins Estradiol Antagonists Premature Birth |