Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Completed

• Conditions: Isthmocele; Uterine Scar Defects; Cesarean Section Complications; Uterine Niche
• Interventions: Procedure: Clinical and ultrasonographic assessment

• Registration Number: NCT04825821
• Lead Sponsor: Ospedale Policlinico San Martino

Brief Summary

Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2021-03-27
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-09-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 247

Inclusion Criteria

• Patients who underwent elective cesarean section at ≥ 37 weeks of gestation

Exclusion Criteria

• Patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization);
• Patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy);
• Patients who had a previous diagnosis of Mullerian uterine anomalies elective cesarean for the second time or after uterine surgery;
• Patients who had evidence of PAS disorders or placenta previa.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low transverse hysterotomy closed by double-layer unidirectional barbed suture	Clinical and ultrasonographic assessment	Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by double-layer unidirectional barbed suture
Low transverse hysterotomy closed by conventional double-layer smooth suture	Clinical and ultrasonographic assessment	Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by conventional double-layer smooth suture

Primary Outcome Measures

Name	Time	Method
Number of uterine scar defects	24 months after the cesarean section	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound

Secondary Outcome Measures

Name	Time	Method
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	24 months after the cesarean section	RMT, depth, width, and length are evaluated by transvaginal ultrasound
Number of patients with postmenstrual spotting	24 months after the cesarean section	Number of patients with postmenstrual spotting is evaluated by medical interview
Number of patients with dysmenorrhea	24 months after the cesarean section	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy