A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix
NCT ID: NCT00694967
Last Updated: 2008-06-11
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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TERMINATED
NA
92 participants
INTERVENTIONAL
2003-11-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
McDonald cerclage
McDonald cerclage placement
Transcervical McDonald cerclage placement
2
17 hydroxyprogesterone caproate
17 hydroxyprogesterone caproate
Weekly 250mg intramuscular injections
Interventions
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McDonald cerclage placement
Transcervical McDonald cerclage placement
17 hydroxyprogesterone caproate
Weekly 250mg intramuscular injections
Eligibility Criteria
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Inclusion Criteria
* Prolapse of the chorio-amniotic membranes into the endocervical canal
* Functional cervical length less than 25mm
* Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure
Exclusion Criteria
* Multiple gestation
* Known allergy to progesterone
* Ruptured membranes
* Vaginal bleeding
* Intra-amniotic infection (diagnosed clinically or by amniocentesis)
* Prolapse of endocervical membranes beyond the external cervical os
* Persistent uterine activity accompanied by cervical change
* Obstetrically indicated delivery.
FEMALE
Yes
Sponsors
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Lehigh Valley Hospital
OTHER
Responsible Party
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Lehigh Valley Hospital
Principal Investigators
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Orion Rust, M.D
Role: PRINCIPAL_INVESTIGATOR
Lehigh Valley Hospital
Locations
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Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Countries
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Other Identifiers
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2003103
Identifier Type: -
Identifier Source: org_study_id
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