17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
August 27, 2011 updated by: Meir Medical Center
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
800
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kfar Saba, Israel
- Meir Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
|
weekly injection of 250 mg until 34 weeks gestation
weekly injection, 250 mg until 34 weeks gestation
|
|
Active Comparator: 2
previous preterm delivery, treatment with daily vaginal natural progesterone
|
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
|
|
Active Comparator: 3
short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
|
weekly injection of 250 mg until 34 weeks gestation
weekly injection, 250 mg until 34 weeks gestation
|
|
Active Comparator: 4
short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
|
daily vaginal progesterone 200 mg until 34 weeks gestation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
efficacy
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
comfort of use and consequently of that compliance
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tal Biron-Shental, MD, Meir Medical Center, Israel, Affiliated to Tel Aviv University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 27, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0129-08-MMC Ver:1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.