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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00809939
• Other study ID #: 0129-08-MMC Ver:1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: August 27, 2011
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• 17 alfa hydroxyprogesterone caproate
weekly injection of 250 mg until 34 weeks gestation
• natural progesterone
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
• 17 alfa hydroxyprogesterone caproate
weekly injection, 250 mg until 34 weeks gestation
• vaginal progesterone
daily vaginal progesterone 200 mg until 34 weeks gestation.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy		3 years	No
Secondary	comfort of use and consequently of that compliance		3 years	No