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OpenTrials
Completed

NCT Number: NCT05166174

Lower Uterine Segment Following a Cesarean Section With Barbed Suture

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.

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Key information

Conditions

Cesarean Wound; Dehiscence Cesarean Section Complications

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Piazza della Vittoria 14

Genoa, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasound in the third trimester pregnancy

Procedure

Ultrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation)

Primary outcomes

  1. Ultrasonographic measure of lower uterine segment thickness

    Time frame: 34-38 weeks following study enrollment

    Measure of lower uterine thickness (mm) at transvaginal ultrasound

Sponsors and collaborators

Lead sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Other

Registry information

Official study title

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

Acronym: BARB-LOWSEGM

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2021
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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