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

Not Applicable

Completed

• Conditions: Cesarean Section Complications

• Registration Number: NCT07101952
• Lead Sponsor: Benha University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-25
• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Patients planned for CS delivery either on emergency or elective bases for singleton fetus in cephalic presentation;
• Patients were free of exclusion criteria;
• Patients who signed the written consent to participate in the study and attend the postpartum follow-up for three months.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Success Rate in Relation to Suture Material	3.5 Months	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.

Trial Locations

Locations (1)

Benha university; 🇪🇬 Banhā, El Qalyoubia, Egypt