17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
NCT ID: NCT00809939
Last Updated: 2011-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
800 participants
INTERVENTIONAL
2010-12-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
17 alfa hydroxyprogesterone caproate
weekly injection of 250 mg until 34 weeks gestation
2
previous preterm delivery, treatment with daily vaginal natural progesterone
natural progesterone
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
3
short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
17 alfa hydroxyprogesterone caproate
weekly injection, 250 mg until 34 weeks gestation
4
short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
vaginal progesterone
daily vaginal progesterone 200 mg until 34 weeks gestation.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
* A singleton gestation.
Exclusion Criteria
* The subject has or will have a cervical cerclage in place.
18 Years
FEMALE
Yes
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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Tal Biron-Shental, MD
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center, Israel, Affiliated to Tel Aviv University
Locations
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Meir Medical Center
Kfar Saba, , Israel
Countries
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Other Identifiers
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0129-08-MMC Ver:1
Identifier Type: -
Identifier Source: org_study_id
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