Incision-Parallel Double-Layer Non-Locking Versus Single-Layer Locked Uterine Closure After Primary Caesarean Delivery: A Randomized Controlled Trial

NCT07841028 | Completed

• 1 other identifier: Karar No: 01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was conducted to compare two uterine closure techniques in women undergoing primary cesarean delivery. The study evaluated whether the technique used to close the uterine incision affects the development and characteristics of cesarean scar defects (CSD). Participants were randomly assigned in a 1:1 ratio to either a conventional single-layer locked continuous uterine closure technique or a double-layer, incision-parallel, nonlocking continuous closure technique. Cesarean scar healing was evaluated at least three months after delivery using transvaginal ultrasonography. The primary outcome was the presence of a cesarean scar defect. Additional ultrasound measurements were used to evaluate the morphology of the cesarean scar and residual myometrial thickness.

Conditions

Cesarean Scar Defect (Isthmococele)

Keywords

Cesarean scar defect; Cesarean scar niche; Residual myometrial thickness; Uterine closure; Locked suture; Nonlocking suture

Outcome Measures

Primary Outcomes (1)

• Incidence of Cesarean Scar Defect

  Cesarean scar defect (CSD) was assessed by transvaginal ultrasonography and defined as a visible hypoechoic indentation at the site of the cesarean scar with a depth of at least 2 mm.

  At least 3 months after cesarean delivery

Secondary Outcomes (2)

• Cesarean Scar Morphometric Measurements

  At least 3 months after cesarean delivery

• Perioperative Hemoglobin Change

  From preoperative assessment to postoperative day 1.

Other Outcomes (1)

• Self-Reported Postpartum Symptoms

  At least 3 months after cesarean delivery

Study Arms (2)

Single-Layer Locked Uterine Closure

ACTIVE COMPARATOR

Participants underwent uterine incision closure using a single-layer locked continuous suturing technique.

Procedure: Single-Layer Locked Uterine Closure

Double-Layer Nonlocking Uterine Closure

EXPERIMENTAL

Participants underwent uterine incision closure using a double-layer, incision-parallel, nonlocking continuous suturing technique.

Procedure: Double-Layer Incision-Parallel Nonlocking Uterine Closure

Interventions

Single-Layer Locked Uterine Closure PROCEDURE

Uterine closure was performed using a single-layer locked continuous suturing technique after cesarean delivery.

Single-Layer Locked Uterine Closure

Double-Layer Incision-Parallel Nonlocking Uterine Closure PROCEDURE

Uterine closure was performed using a double-layer, incision-parallel, continuous nonlocking suturing technique. Primary corner sutures were placed at both ends of the uterine incision. In the first layer, the lower-segment myometrium was approximated with full-thickness nonlocking sutures placed parallel to the incision, with corresponding bites taken from the upper segment at the same level. The second layer consisted of continuous nonlocking approximation of the serosal-subserosal tissue.

Double-Layer Nonlocking Uterine Closure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years Undergoing first cesarean delivery Early-term, term, or post-term pregnancy Elective or emergency indication for cesarean delivery Provided written informed consent

You may not qualify if:

• Previous cesarean delivery Congenital uterine anomaly Chronic anemia Uncontrolled gestational or pregestational diabetes mellitus Uncontrolled hypertension Severe preeclampsia Body mass index \>30 kg/m² Active labor lasting \>5 hours Cervical dilatation \>5 cm at cesarean delivery

Sponsors & Collaborators

• Onur Karaaslan: lead

Study Sites (1)

Van Yuzuncu Yil University Faculty of Medicine

Van, Van, 65000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator performing the postpartum transvaginal ultrasonography and assessing the uterine scar was blinded to treatment allocation. Participants were instructed not to disclose their assigned uterine closure technique to the outcome assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: June 17, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)