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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorAnkara City Hospital Bilkent

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female participants aged 18-44 years.

Undergoing cesarean delivery at the study hospital's Obstetrics and Gynecology clinic.

Disqualifiers

Suspected or confirmed placenta previa or placenta accreta spectrum.

Clinical chorioamnionitis.

Anterior wall uterine myomas.

History of low transverse nonstandard uterine incision.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Double-Layer Cesarean Scar Repair

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Double-Layer Cesarean Scar RepairExperimental treatment 1 intervention
Group B: Single-Layer Cesarean Scar RepairExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Myometrial Thickness at Cesarean Scar Site

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).

Time frame
6 months postoperatively

Secondary outcomes

1

Cesarean Scar-Related Symptoms

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, %)

Time frame
6 months postoperatively
2

Cesarean Scar Defect (Isthmocele)

Presence of cesarean scar defect (isthmocele) detected by transvaginal ultrasonography. Measurement Tool / Method: Transvaginal ultrasonography. Units of Measure: Incidence (number of participants with isthmocele, %)

Time frame
6 months postoperatively
3

Major Uterine Scar-Related Complications

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, %)

Time frame
Up to 6 months postoperatively
4

Morphological Characteristics of Cesarean Scar Defect

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)

Time frame
6 months postoperatively

Other outcomes

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