Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331695
Status:
COMPLETED
Last Update Posted:
2011-05-09
First Post:
2006-05-30
Brief Title:
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 06012006 to 12312008 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
nauseavomiting
weakness
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 06012006 to 12312008 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
nauseavomiting
weakness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None