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A Two-Layered Simple Interrupted Myometrial Suturing Reduces Uterine Niche Formation After Primary Cesarean Section

NCT07229222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-02-27

No results posted yet for this study

Summary

The purpose of the study is to determine whether two-layered simple interrupted myometrial suturing is superior to double-layered continuous suturing for the prevention of uterine niche formation after primary cesarean section.

Conditions

  • Cesarean Section Complications
  • Scar Niche
  • Myometrial Remodeling
  • Suture Techniques

Interventions

PROCEDURE

Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium

All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where two-layered simple interrupted suturing of the myometrium was applied.

PROCEDURE

Primary Cesarean Section with double-layered continuous suturing of the myometrium

All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where double-layered continuous suturing of the myometrium was applied.

DIAGNOSTIC_TEST

Saline-infusion Sonohysterography

At 6 months postpartum, all patients were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

  • AHMED ALNEZAMY, MD · Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2025-06-15
Completion
2025-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229222 on ClinicalTrials.gov