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

Onur Karaaslan60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cesarean Scar Defect (Isthmococele)

Interventions

Double-Layer Incision-Parallel Nonlocking Uterine ClosurePROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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

Outcomes

Primary Outcomes

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.

Time frame: At least 3 months after cesarean delivery

Secondary Outcomes

Cesarean Scar Morphometric Measurements

Cesarean scar morphology was assessed by transvaginal ultrasonography. Measurements included scar indentation depth and length, residual myometrial thickness (RMT), adjacent myometrial thickness (AMT), uterovesical fold distance, vesicovaginal fold distance, and the distance between the scar indentation and the external cervical os. Measurements were expressed in millimeters. Scar indentation morphology was also recorded. When no indentation was visible, indentation depth and length were recorded as 0 mm, and external os distance was considered not applicable.

Time frame: At least 3 months after cesarean delivery

Perioperative Hemoglobin Change

Hemoglobin levels were measured preoperatively and on postoperative day 1. Hemoglobin reduction was calculated as the preoperative hemoglobin value minus the postoperative day-1 value and was expressed in g/dL.

Time frame: From preoperative assessment to postoperative day 1.