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NCT Number: NCT07323355

Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness

Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with a rising incidence particularly in high-income countries. Although often life-saving, cesarean delivery carries both short- and long-term maternal risks. Early complications include infection, hemorrhage, and thromboembolism, while inadequate uterine healing can lead to future complications such as uterine rupture and placenta accreta spectrum disorders. Additionally, cesarean scars may result in pregnancy complications, isthmocele formation, postmenstrual bleeding, pelvic pain, and dysmenorrhea. This highlights the need for optimization of the surgical technique. Despite increasing cesarean rates, there is no consensus on the optimal uterine closure method. Techniques vary in terms of the number of layers, suture locking style, and inclusion of the endometrium, and their comparative effectiveness in reducing scar defects remains unclear. Some previous studies have reported increased uterine rupture risk with single-layer locked sutures and better healing with double-layer closure, while others found no significant difference in scar outcomes. This study aims to investigate the effects of single- versus double-layer cesarean scar closure on myometrial thickness and its clinical implications.

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Key information

Conditions

Caesarean Section Cesarean Scar Closure Cesarean Scar Defect (Isthmococele) Clinical Outcomes Myometrial Thickness Postpartum Complications

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Not Valid, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Merve Didem Eşkin Tanrıverdi, MD

CONTACT

[email protected]

+903125526000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Double-Layer Cesarean Scar Repair

Procedure

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.

Single-Layer Cesarean Scar Repair

Procedure

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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, %)

  2. 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, %)

  3. 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, %)

  4. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Merve Didem Eşkin Tanrıverdi, MD

CONTACT

[email protected]

+905354071467

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effects of Single-Layer Versus Double-Layer Cesarean Scar Repair on Myometrial Thickness and Associated Clinical Outcomes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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