Lower Uterine Segment Following a Cesarean Section With Barbed Suture

NCT05166174 | Completed

• 1 other identifier: BARB-LOWSEGM
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Wound; Dehiscence; Cesarean Section Complications

Keywords

barbed suture; uterine lower segment; cesarean section

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic measure of lower uterine segment thickness

  Measure of lower uterine thickness (mm) at transvaginal ultrasound

  34-38 weeks following study enrollment

Study Arms (2)

Pregnant women who underwent previous cesarean section with barbed suture

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").

Procedure: Transvaginal ultrasound in the third trimester pregnancy

Pregnant women who underwent previous cesarean section with conventional smooth suture

This group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed conventional smooth suture.

Procedure: Transvaginal ultrasound in the third trimester pregnancy

Interventions

Transvaginal ultrasound in the third trimester pregnancy PROCEDURE

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

Pregnant women who underwent previous cesarean section with barbed suture; Pregnant women who underwent previous cesarean section with conventional smooth suture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who underwent a previous elective cesarean section at term of pregnancy, during which the anteriore uterine wall was closed by using barbed or conventional smooth suture

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia: lead

Study Sites (1)

Piazza della Vittoria 14

Genoa, Italy

Location

Related Publications (2)

• Jastrow N, Chaillet N, Roberge S, Morency AM, Lacasse Y, Bujold E. Sonographic lower uterine segment thickness and risk of uterine scar defect: a systematic review. J Obstet Gynaecol Can. 2010 Apr;32(4):321-327. doi: 10.1016/S1701-2163(16)34475-9.

  PMID: 20500938 BACKGROUND

• Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.

  PMID: 34146146 BACKGROUND

Study Officials

• Simone Ferrero

  Piazza della Vittoria 14, Genoa, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

IT (1)