Evaluation of Cesarean Scar After Three Different Uterine Closure Technis
1 other identifier
interventional
90
1 country
1
Brief Summary
The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2020
CompletedMay 11, 2020
May 1, 2020
1 year
April 10, 2019
May 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Residual myometrial thickness
Myometrial thickness at the uterine scar by transvaginal ultrasound
6 months after cesarean
Secondary Outcomes (8)
Existence of cesarean scar defect
6 months after cesarean
Width of defect
6 months after cesarean
Depth of defect (niche)
6 months after cesarean
Operation time
10 minute after cesarean completed
Change in hemoglobin
48 hours after cesarean
- +3 more secondary outcomes
Study Arms (3)
Single layer closure
ACTIVE COMPARATORDouble layer closure
ACTIVE COMPARATORDoble layer closure with trimming
ACTIVE COMPARATORInterventions
Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.
The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
Eligibility Criteria
You may qualify if:
- Previous two or three cesarean
- Gestational weeks \>=36 weeks
You may not qualify if:
- Risk of obstetric haemorrhage
- Suspicion or diagnosis placenta previa or accrete syndrome
- Chorioamnionitis
- Uterine myoma in the anterior uterine segment
- Hysterotomy other than lower segment uterine incision at previous cesarean
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University Hospital
Erzurum, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffesor in dept. of obstetrics and gynecology
Study Record Dates
First Submitted
April 10, 2019
First Posted
April 16, 2019
Study Start
April 16, 2019
Primary Completion
April 16, 2020
Study Completion
April 16, 2020
Last Updated
May 11, 2020
Record last verified: 2020-05