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

Preterm Delivery Clinical Trial

Official title:

Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331695
• Other study ID #: P040438
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: May 6, 2011
• Start date: June 2006
• Est. completion date: May 2010

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Intervention

Drug:
• 17 alpha-hydroxyprogesterones caproate
17 alpha-hydroxyprogesterones caproate

Locations

Country	Name	City	State
France	CHI Poissy st Germain	Poissy
France	Chi Poissy St Germain	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interval between inclusion and delivery.	Interval between inclusion and delivery.	during de study	Yes
Secondary	Preterm delivery rate < 37 W, < 34 W et < 32 W,	Preterm delivery rate < 37 W, < 34 W et < 32 W,	during the study	Yes
Secondary	Number of hospitalizations for preterm labor,	Number of hospitalizations for preterm labor,	during the study	Yes
Secondary	Cerclage performed at or after 20 weeks,	Cerclage performed at or after 20 weeks,	during the study	Yes
Secondary	Neonatal weight,	Neonatal weight,	during the study	Yes
Secondary	NICU transport	NICU transport	during the study	Yes
Secondary	Respiratory distress syndrome,	Respiratory distress syndrome,	during the study	Yes
Secondary	Bronchopulmonary dysplasia,	Bronchopulmonary dysplasia,	during the study	Yes
Secondary	Necrotizing enterocolitis,	Necrotizing enterocolitis,	during the study	Yes
Secondary	leucomalacia,	leucomalacia,	during the study	Yes
Secondary	neonatal death.	neonatal death.	during the study	Yes