Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM
NCT ID: NCT02673359
Last Updated: 2023-04-10
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
PHASE4
220 participants
INTERVENTIONAL
2016-02-29
2024-01-31
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
SINGLE
Study Groups
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Progesterone group
Vaginal progesterone suppositories will be given
Progesterone
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Cerclage group
Cervical cerclage will be performed.
Cervical cerclage
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
Interventions
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Progesterone
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Cervical cerclage
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
* Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.
Exclusion Criteria
* Congenital uterine malformation.
* Multifetal pregnancy.
* Known major fetal structural or chromosomal abnormality.
* Known allergy or contraindication (relative or absolute) to progesterone therapy.
* Presence of contraindication to cervical cerclage.
* Medical conditions complicating pregnancy.
* Vaginal bleeding.
20 Years
35 Years
FEMALE
No
Sponsors
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Mohamed Sayed Abdelhafez
OTHER
Responsible Party
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Mohamed Sayed Abdelhafez
Dr
Principal Investigators
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Waleed El-refaie, Dr
Role: PRINCIPAL_INVESTIGATOR
Port Said University
Mohamed S Abdelhafez, Dr
Role: STUDY_DIRECTOR
Mansoura University
Ahmed M Badawy, Prof
Role: STUDY_CHAIR
Mansoura University
Locations
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Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Private practice settings
Al Mansurah, Dakahlia Governorate, Egypt
Obstetrics and Gynecology Department in Port Said University
Port Said, , Egypt
Countries
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Central Contacts
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Other Identifiers
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WR2
Identifier Type: -
Identifier Source: org_study_id
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