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

NCT ID: NCT07101952

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2024-10-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Vicryl group

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.

Group Type: ACTIVE_COMPARATOR

Multifilament vicryl suture material

Intervention Type: 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.

Barbed absorbable synthetic monofilament group

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.

Group Type: ACTIVE_COMPARATOR

Braded Suture material

Intervention Type: 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.

Interventions

Braded Suture material

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.

Intervention Type: OTHER

Multifilament vicryl suture material

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.

Intervention Type: OTHER

Other Intervention Names

Absorbable synthetic monofilament polydioxanone with bars

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Basma Sakr

Assistant Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha university

Banhā, El Qalyoubia, Egypt

Countries

Egypt

Other Identifiers

RC 2-11-2024

Identifier Type: -

Identifier Source: org_study_id