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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate

NCT00120640

Premature Birth Premature Labor

WITHDRAWN NA

Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

NCT01317225

Preterm Birth Obstetric Labor, Premature

UNKNOWN PHASE3

17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

NCT03779438

Placenta Previa

UNKNOWN NA

Progestagens for the Tertiary Prophylaxis of Preterm Delivery

NCT01178788

Preterm Delivery Neonatal Complications

COMPLETED PHASE3

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

NCT00809939

Pregnancy

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

17 alpha-hydroxyprogesterones caproate

Group Type EXPERIMENTAL

17 alpha-hydroxyprogesterones caproate

Intervention Type DRUG

17 alpha-hydroxyprogesterones caproate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

17 alpha-hydroxyprogesterones caproate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No