- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323355
Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness
Effects of Single-Layer Versus Double-Layer Cesarean Scar Repair on Myometrial Thickness and Associated Clinical Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve Didem Eşkin Tanrıverdi, MD
- Phone Number: +905354071467
- Email: mrvddm@hotmail.com
Study Locations
-
-
Not Valid
-
Ankara, Not Valid, Turkey (Türkiye), 06100
- Recruiting
- Ankara Bilkent City Hospital
-
Contact:
- Merve Didem Eşkin Tanrıverdi, MD
- Phone Number: +903125526000
- Email: mrvddm@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female participants aged 18-44 years.
- Undergoing cesarean delivery at the study hospital's Obstetrics and Gynecology clinic.
- Evaluated as clinically eligible based on history, physical examination, abdominal ultrasonography, and routine preoperative laboratory tests, including:
Complete blood count (CBC), biochemical profile, prothrombin time (PT), activated partial thromboplastin time (aPTT), blood group determination. No abnormalities detected in the above assessments.
Exclusion Criteria:
- Presence of chronic diseases, including: Rheumatologic diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, thyroid disease, congenital hematologic disorders.
- Suspected or confirmed placenta previa or placenta accreta spectrum.
- Clinical chorioamnionitis.
- Anterior wall uterine myomas.
- History of low transverse nonstandard uterine incision.
- Predicted obstetric hemorrhage or other intraoperative complications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Double-Layer Cesarean Scar Repair
Participants in this arm receive double-layer closure of the cesarean section scar according to the study protocol.
Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured.
This arm is compared in parallel with the single-layer cesarean scar repair arm.
|
Participants in this arm undergo double-layer closure of the uterine incision during cesarean delivery.
The procedure involves suturing the full thickness of the myometrium in the first layer, followed by a second continuous suture approximating the outer myometrium and serosa.
Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured.
This arm is compared in parallel with the single-layer cesarean scar repair arm.
|
|
Experimental: Single-Layer Cesarean Scar Repair
Participants in this arm receive single-layer closure of the cesarean section scar according to the study protocol.
Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured.
This arm is compared in parallel with the double-layer cesarean scar repair arm.
|
Participants in this arm undergo single-layer closure of the uterine incision during cesarean delivery.
The procedure involves a single continuous suture approximating the full thickness of the uterine wall.
Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured.
This arm is compared in parallel with the double-layer cesarean scar repair arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myometrial Thickness at Cesarean Scar Site
Time Frame: 6 months postoperatively
|
Myometrial thickness at the cesarean scar site will be measured using transvaginal ultrasonography (TVUSG) by a qualified obstetrician at 6 months after surgery to compare the effects of single-layer versus double-layer cesarean scar closure. Measurement Tool / Parameter: TVUSG; residual myometrial thickness (mm). Units of Measure: Millimeters (mm). |
6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cesarean Scar-Related Symptoms
Time Frame: 6 months postoperatively
|
Presence of cesarean scar-related symptoms at 6 months after surgery. Parameters Assessed: Postmenstrual spotting (yes/no), pelvic pain (yes/no), dyspareunia (yes/no) Measurement Tool / Method: Clinical interview during follow-up visit and review of outpatient medical records. Units of Measure: Incidence (n, %) |
6 months postoperatively
|
|
Cesarean Scar Defect (Isthmocele)
Time Frame: 6 months postoperatively
|
Presence of cesarean scar defect (isthmocele) detected by transvaginal ultrasonography. Measurement Tool / Method: Transvaginal ultrasonography. Units of Measure: Incidence (number of participants with isthmocele, %) |
6 months postoperatively
|
|
Major Uterine Scar-Related Complications
Time Frame: Up to 6 months postoperatively
|
Occurrence of major uterine scar-related complications within 6 months after surgery. Parameters Assessed: Uterine rupture, cesarean scar pregnancy, abnormal uterine bleeding Measurement Tool / Method: Clinical examination and medical record review. Units of Measure: Incidence (n, %) |
Up to 6 months postoperatively
|
|
Morphological Characteristics of Cesarean Scar Defect
Time Frame: 6 months postoperatively
|
Morphological characteristics of cesarean scar defect measured by transvaginal ultrasonography. Parameters Assessed: Isthmocele depth (mm), isthmocele width (mm) Measurement Tool / Method: Transvaginal ultrasonography. Units of Measure: Millimeters (mm) |
6 months postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TABED 1-25-1872
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Caesarean Section
-
Ashulia Women and Children HospitalCompleted
-
Assiut UniversityCompletedCaesarean SectionEgypt
-
Taipei Medical University WanFang HospitalCompletedCaesarean SectionTaiwan
-
South Tees Hospitals NHS Foundation TrustCompletedCaesarean Section | Caesarean Section; InfectionUnited Kingdom
-
Sichuan Provincial People's HospitalNot yet recruiting
-
Shanghai First Maternity and Infant HospitalUnknownCaesarean SectionChina
-
Karamanoğlu Mehmetbey UniversityRecruitingCaesarean SectionTurkey (Türkiye)
-
Büşra KüçüktürkmenNot yet recruiting
-
Maimonides Medical CenterTerminatedCaesarean SectionUnited States
Clinical Trials on Double-Layer Cesarean Scar Repair
-
Zagazig UniversityRecruitingCesarean Scar NicheEgypt
-
Ataturk UniversityUnknownCesarean Section Complications | Cesarean Section; Complications, Wound, Dehiscence | Cesarean Section, Repeated | Cesarean, Uterine Scar Thickness | Cesarean, Residual Myometrial ThicknessTurkey
-
Hédi Chaker HospitalCompletedPelvic Pain | Metrorrhagia | Amenorrhea Secondary | Spotting | Cesarean Scar Defect (Isthmococele)Tunisia
-
Benha UniversityCompletedCesarean Section Complications | Scarred Uterus | Scar NicheEgypt
-
Sohag UniversityRecruitingCesarean Scar PregnancyEgypt
-
Tanta UniversityCompletedCaesarean Section | Transvaginal Ultrasound | Uterine Scar | Single Layer | Double LayerEgypt
-
Austrian Research Group for Regenerative and Orthopedic...UnknownRotator Cuff TearAustria
-
Ain Shams UniversityCompletedGuided Bone RegenerationEgypt
-
Ataturk UniversityCompletedCesarean Section, Repeated | Cesarean, Uterine Scar Thickness | Cesarean, Residual Myometrial ThicknessTurkey