- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809939
17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
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
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Kfar Saba, Israel
- Meir Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Tal Biron-Shental, MD, Meir Medical Center, Israel, Affiliated to Tel Aviv University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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