Suture Material and C-Section Scar Niches: A Comparative Study

NCT07101952 | Completed

• 1 other identifier: RC 2-11-2024
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Defective healing of the uterine wound after a Cesarean section (CS) can lead to the formation of a CS niche (CSN). The specific technique used for closure and the type of suture material chosen are often overlooked factors that might contribute to the development of these niches. This study aimed to compare how frequently CSNs occur when the CS hysterotomy is closed using barbed suture material versus conventional vicryl suture material, with assessments primarily done via transvaginal ultrasound (TVS). The methodology involved closing the CS hysterotomy with a double-layer technique using unlocked continuous running sutures, where the first layer included the decidua and was overlapped by the second. Researchers evaluated several aspects, including the duration and feasibility of the hysterotomy closure, the grade of postoperative pain, and the length of hospital stay. Transvaginal ultrasounds were conducted monthly for three months post-operatively to monitor for CSN development and to gather descriptive measurements of any niches found. The absence of a CSN was considered an indicator of surgical success.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Surgical Success Rate in Relation to Suture Material

  The comparison of the overall surgical success rate, defined by the absence of a Cesarean section niche (CSN), between groups using different suture materials, alongside the quantitative differences in descriptive metrics of any formed CSNs.

  3.5 Months

Study Arms (2)

Vicryl group

ACTIVE COMPARATOR

In these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was conventional multifilament Vicryl.

Other: Multifilament vicryl suture material

Barbed absorbable synthetic monofilament group

ACTIVE COMPARATOR

In these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.

Other: Braded Suture material

Interventions

Braded Suture material OTHER

The Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.

Also known as: Absorbable synthetic monofilament polydioxanone with bars

Barbed absorbable synthetic monofilament group

Multifilament vicryl suture material OTHER

The Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.

Vicryl group

Eligibility Criteria

• Age: 22 Years - 47 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients planned for CS delivery either on emergency or elective bases for singleton fetus in cephalic presentation;

You may not qualify if:

• Patients who signed the written consent to participate in the study and attend the postpartum follow-up for three months.
• Patients who had multiple pregnancy;
• Patients who had fetus in abnormal lie or presentation;
• Patients who had previous repair of CSN;
• Patients with uncontrolled DM or hypertension;
• Patients who had maintained on immunosuppressive therapies, had autoimmune disorders;
• Patients who refused to sign the written consent were excluded from the study.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 3, 2025
• Study Start: July 12, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 25, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

EG (1)