- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00331695
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Poissy, France, 78303
- Chi Poissy St Germain
-
Poissy, France, 78
- Chi Poissy St Germain
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
17 alpha-hydroxyprogesterones caproate
|
17 alpha-hydroxyprogesterones caproate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interval between inclusion and delivery.
Time Frame: during de study
|
Interval between inclusion and delivery.
|
during de study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,
|
during the study
|
Number of hospitalizations for preterm labor,
Time Frame: during the study
|
Number of hospitalizations for preterm labor,
|
during the study
|
Cerclage performed at or after 20 weeks,
Time Frame: during the study
|
Cerclage performed at or after 20 weeks,
|
during the study
|
Neonatal weight,
Time Frame: during the study
|
Neonatal weight,
|
during the study
|
NICU transport
Time Frame: during the study
|
NICU transport
|
during the study
|
Respiratory distress syndrome,
Time Frame: during the study
|
Respiratory distress syndrome,
|
during the study
|
Bronchopulmonary dysplasia,
Time Frame: during the study
|
Bronchopulmonary dysplasia,
|
during the study
|
Necrotizing enterocolitis,
Time Frame: during the study
|
Necrotizing enterocolitis,
|
during the study
|
leucomalacia,
Time Frame: during the study
|
leucomalacia,
|
during the study
|
neonatal death.
Time Frame: during the study
|
neonatal death.
|
during the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick ROZENBERG, MD,, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9. doi: 10.1097/01.AOG.0000143254.27255.e9.
- Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssiere C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Premature Birth
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Progestins
- 17 alpha-Hydroxyprogesterone Caproate
- 11-hydroxyprogesterone
Other Study ID Numbers
- P040438
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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