Lower Uterine Segment Following a Cesarean Section With Barbed Suture

Completed

• Conditions: Cesarean Wound; Dehiscence; Cesarean Section Complications
• Interventions: Procedure: Transvaginal ultrasound in the third trimester pregnancy

• Registration Number: NCT05166174
• Lead Sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Brief Summary

This aim of this study is to investigate the LUS in the pregnancy following a previous cesarean section with the use of barbed or conventional smooth suture.

Detailed Description

To better assess the risk of uterine rupture, some authors have proposed sonographic measurement of lower uterine segment (LUS) thickness near term, assuming that there is an inverse correlation between LUS thickness and the risk of uterine scar defect. Recently, barbed suture has been employed for closing uterine wall after cesarean section, demonstrating the reduction of closure time of the uterine incision and estimated blood loss. Until now, the impact of barbed suture in future pregnancies has not been investigated.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

• pregnant women
• being undergone a previous elective cesarean section at term of pregnancy (more than 37 weeks of gestation), in which barbed or conventional smooth suture was used for closing anterior uterine wall

Exclusion Criteria

• having done more than one cesarean section
• having done a previous urgent cesarean section
• having done previous uterine surgical procedures with exception than one cesarean section

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women who underwent previous cesarean section with barbed suture	Transvaginal ultrasound in the third trimester pregnancy	This group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed by using barbed suture ("Fish-bone suture").
Pregnant women who underwent previous cesarean section with conventional smooth suture	Transvaginal ultrasound in the third trimester pregnancy	This group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed conventional smooth suture.

Primary Outcome Measures

Name	Time	Method
Ultrasonographic measure of lower uterine segment thickness	34-38 weeks following study enrollment	Measure of lower uterine thickness (mm) at transvaginal ultrasound

Trial Locations

Locations (1)

Piazza della Vittoria 14; 🇮🇹 Genoa, Italy