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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02962011 |
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Date of registration:
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09/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
barbed |
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Scientific title:
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Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section |
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Date of first enrolment:
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August 1, 2016 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02962011 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 3
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Countries of recruitment
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Israel
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Contacts
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Name:
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David Peleg |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ziv Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- elective cesarean
- elective repeat cesarean
Exclusion Criteria:
- emergent or urgent cesarean
- PROM
- chorioamninitis
- placental abruption
- placenta previa or accreta
- known uterine fibroids
- women with known medical problems such as coagulopathy
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cesarean Section
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Intervention(s)
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Device: polyglactin 910
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Device: Knotless barbed suture
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Primary Outcome(s)
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Uterine incision closure time
[Time Frame: 5 months]
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Secondary Outcome(s)
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uterine incision blood loss
[Time Frame: 5 months]
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hemostatic suture use
[Time Frame: 5 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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