NCT00809939

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries. The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	17 alfa hydroxyprogesterone caproate	weekly injection of 250 mg until 34 weeks gestation
DRUG	natural progesterone	previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
DRUG	17 alfa hydroxyprogesterone caproate	weekly injection, 250 mg until 34 weeks gestation
DRUG	vaginal progesterone	daily vaginal progesterone 200 mg until 34 weeks gestation.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-12-17
• Last updated: 2011-08-30

Locations

1 site across 1 country: Israel