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

Phase 3

• Conditions: Pregnancy
• Interventions: Drug: natural progesterone; Drug: 17 alfa hydroxyprogesterone caproate; Drug: vaginal progesterone

• Registration Number: NCT00809939
• Lead Sponsor: Meir Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-27
• Last Update Posted: 2011-08-30
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

• The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
• The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
• A singleton gestation.

Exclusion Criteria

• Multifetal pregnancy.
• The subject has or will have a cervical cerclage in place.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	natural progesterone	previous preterm delivery, treatment with daily vaginal natural progesterone
1	17 alfa hydroxyprogesterone caproate	previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
3	17 alfa hydroxyprogesterone caproate	short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
4	vaginal progesterone	short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.

Primary Outcome Measures

Name	Time	Method
efficacy	3 years

Secondary Outcome Measures

Name	Time	Method
comfort of use and consequently of that compliance	3 years

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel