Single Layer With Unlocked Sutures Versus Double Layer Closure of Cesarean Incision and the Risk of Niche Development

NCT07554001 | Completed

• 1 other identifier: KFSIRB200-106
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the development of the uterine niche after single and double closure of cesarean incision.

Conditions

Unlocked Sutures; Double Layer Closure; Niche Development; Single Layer; Cesarean Incision

Outcome Measures

Primary Outcomes (1)

• Assessment of the presence of niche

  Patient were asked about any symptoms of the niche like post menstrual spotting as brownish discharge for more than two days at the end of menses or spotting more than seven days or inter menstrual blood loss that start after the end of menses or dysmenorrhea and prolonged bleeding

  6 months after the procedure

Study Arms (2)

Group I

EXPERIMENTAL

Patients underwent uterine scar closure by single layer unlocked sutures.

Procedure: Single layer unlocked sutures

Group II

EXPERIMENTAL

Patients underwent uterine scar closure by double layer unlocked sutures.

Procedure: Double layer unlocked sutures

Interventions

Double layer unlocked sutures PROCEDURE

Patients underwent uterine scar closure by double layer unlocked sutures.

Group II

Single layer unlocked sutures PROCEDURE

Patients underwent uterine scar closure by single layer unlocked sutures.

Group I

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women underwent cesarean section (CS).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Women who undergo first elective cesarean section (CS).

You may not qualify if:

• Women with a previous CS
• Inadequate possibility for counselling (e.g. indication for CS without being informed about the study previously, women in severe pain without adequate therapy
• previous major uterine surgery (e.g. laparoscopic or laparotomy fibroid resection, septum resection), Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro salpinx, uterine anomaly
• Placenta increta or percreta during the current pregnancy
• ≥ Three foetuses during the current pregnancy.
• Placenta previa
• Twins

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology Department, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)