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

• ClinicalTrials.gov Identifier: NCT00331695
• Recruitment Status: Completed
• First Posted: May 31, 2006
• Last Update Posted: May 9, 2011
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by: Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Delivery	Drug: 17 alpha-hydroxyprogesterones caproate	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
• Study Start Date: June 2006
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 17 alpha-hydroxyprogesterones caproate	Drug: 17 alpha-hydroxyprogesterones caproate; 17 alpha-hydroxyprogesterones caproate

Outcome Measures

Primary Outcome Measures :

1. Interval between inclusion and delivery. [ Time Frame: during de study ]
   Interval between inclusion and delivery.

Secondary Outcome Measures :

1. 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,
2. Number of hospitalizations for preterm labor, [ Time Frame: during the study ]
   Number of hospitalizations for preterm labor,
3. Cerclage performed at or after 20 weeks, [ Time Frame: during the study ]
   Cerclage performed at or after 20 weeks,
4. Neonatal weight, [ Time Frame: during the study ]
   Neonatal weight,
5. NICU transport [ Time Frame: during the study ]
   NICU transport
6. Respiratory distress syndrome, [ Time Frame: during the study ]
   Respiratory distress syndrome,
7. Bronchopulmonary dysplasia, [ Time Frame: during the study ]
   Bronchopulmonary dysplasia,
8. Necrotizing enterocolitis, [ Time Frame: during the study ]
   Necrotizing enterocolitis,
9. leucomalacia, [ Time Frame: during the study ]
   leucomalacia,
10. neonatal death. [ Time Frame: during the study ]
    neonatal death.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

France

CHI Poissy st Germain

Poissy, France, 78303

Chi Poissy St Germain

Poissy, France, 78

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Patrick ROZENBERG, MD,; Assistance Publique - Hôpitaux de Paris

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssière C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstétrique et Gynécologie. 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.

• Responsible Party: Christophe AUCAN, Department of Clinical Research of developpement
• ClinicalTrials.gov Identifier: NCT00331695
• Other Study ID Numbers: P040438
• First Posted: May 31, 2006
• Last Update Posted: May 9, 2011
• Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Progesterone; Preterm delivery; Preterm labor; Cervical length; ultrasonography

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Progestins; Hormones