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Clinical Trials/NCT05166174
NCT05166174CompletedNot Applicable

Lower Uterine Segment at the Next Pregnancy Following a Cesarean Section With Barbed Suture: an Observational Prospective Comparative Study

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia1 site in 1 country93 target enrollmentStarted: January 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
93
Locations
1
Primary Endpoint
Ultrasonographic measure of lower uterine segment thickness

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Ultrasonographic measure of lower uterine segment thickness

Time Frame: 34-38 weeks following study enrollment

Measure of lower uterine thickness (mm) at transvaginal ultrasound

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Simone Ferrero

Clinical professor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Study Sites (1)

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