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

February 25, 2026 updated by: Ahmed Abdel Latif Ahmed Alnezamy, Benha University

Decidual-Sparing Two-Layered Simple Interrupted Myometrial Suturing With Visceral Peritoneal Closure Reduces Uterine Niche Formation After Primary Cesarean Section: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All primigravidae at or beyond 28 weeks' gestation undergoing primary cesarean section for any indication were assessed for eligibility. All participants provided written informed consent before enrolment. All patients received preoperative antibiotic prophylaxis at induction of anesthesia and postoperative prophylaxis for 24 h. A single intramuscular dose of oxytocin 10 IU was administered during the first 24 h postpartum. After confirming eligibility and obtaining consent, a trained nurse selected an envelope for each patient and revealed the allocation to the operating obstetrician. Patients were blinded to group allocation.

  • Study Group: Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.
  • Control Group: Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.

The parietal peritoneum was left open in all cases. Hemostasis was ensured, and the number of additional hemostatic sutures was recorded. A braided polyglycolic acid 0-1 suture was used in all cases. All other steps of cesarean section were standardized.

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.

Menstrual history was obtained by an independent obstetrician/gynecologist, documenting spotting days, total bleeding days, amenorrhea, and contraceptive use.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13512
        • Benha Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acceptance to participate and willingness to attend follow-up for 6 months postpartum.
  • No plans for pregnancy within the follow-up period.

Exclusion Criteria:

  • Known Müllerian anomalies or uterine fibroids.
  • Previous uterine surgery.
  • Multiple gestation.
  • Chorioamnionitis, placenta previa, or placental abruption.
  • Preeclampsia/eclampsia.
  • Hepatic or renal dysfunction, uncontrolled diabetes, or systemic disease.
  • Peripartum hemoglobin < 10 g/dL.
  • Chronic corticosteroid use or smoking.
  • Inability to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Two-layered simple interrupted suturing of the myometrium
Two-layered simple interrupted suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.
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.
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.
Active Comparator: Double-layered continuous suturing of the myometrium.
Double-layered continuous suturing of the myometrium, sparing the decidua, with closure of the visceral uterine peritoneum.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of uterine niche formation after primary cesarean section.
Time Frame: At 6 months postpartum
Using saline-infusion sonohysterography (2D, sagittal and coronal views), a niche was defined as ≥ 2 mm myometrial indentation at the scar site.
At 6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine niche measurements
Time Frame: At 6 months postpartum
Using saline-infusion sonohysterography (2D, sagittal and coronal views),niche depth, length, width, and residual myometrial thickness are to be recorded.
At 6 months postpartum
Total operative time.
Time Frame: Intraoperative
The operation room nurse recorded the time lapse between the skin incision and the end of skin suturing.
Intraoperative
The correlation between niche width and menstrual cycle abnormalities.
Time Frame: At 6 months postpartum
For participants diagnosed with uterine niche, menstrual history was obtained by an independent obstetrician/gynecologist, documenting spotting days, total bleeding days, amenorrhea, and contraceptive use.
At 6 months postpartum
The association between active labour at the time of cesarean and niche formation.
Time Frame: Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum
Active labour in primigravida was identified when the cervical dilatation is equal to or more than 3 cm.
Cervical dilatation was evaluated immediately preoperative, while the association was evaluated at 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC13-2-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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