Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section
Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing
1 other identifier
interventional
70
1 country
1
Brief Summary
We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness 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 Aug 2018
Shorter than P25 for not_applicable
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
July 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedStudy Start
First participant enrolled
August 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedAugust 24, 2018
August 1, 2018
8 months
July 6, 2018
August 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
residual myometrial thickness
Myometrial thickness at the uterine scar by transvaginal ultrasound
6 months after cesarean
Secondary Outcomes (10)
residual myometrial thickness
6 weeks after cesarean
Healing ratio
6 months after cesarean
Healing ratio
6 weeks after cesarean
Existence of cesarean scar defect
6 months after cesarean
Existence of cesarean scar defect
6 weeks after cesarean
- +5 more secondary outcomes
Study Arms (2)
Single layer
PLACEBO COMPARATORSingle layer closure
Double layer with resection
ACTIVE COMPARATORDouble layer closure after resection uterine scar
Interventions
Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.
Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.
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)
Atatürk Üniversitesi araştırma Hastanesi
Erzurum, 25240, Turkey (Türkiye)
Related Publications (1)
Ozler MR, Al RA. A prospective comparative study of single-layer versus double-layer uterine closure techniques on cesarean scar formation. BMC Pregnancy Childbirth. 2025 Aug 20;25(1):868. doi: 10.1186/s12884-025-08010-3.
PMID: 40836292DERIVED
MeSH Terms
Conditions
Central Study Contacts
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
- Professor in obstetrics And gynecology
Study Record Dates
First Submitted
July 6, 2018
First Posted
August 23, 2018
Study Start
August 23, 2018
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
August 24, 2018
Record last verified: 2018-08