Lower Uterine Segment Following a Cesarean Section With Barbed Suture (BARB-LOWSEGM)

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Cesarean Wound; Dehiscence
• Intervention / Treatment: Procedure: Transvaginal ultrasound in the third trimester pregnancy

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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy
    • Piazza della Vittoria 14

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Ultrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation)
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; Ultrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Investigators: Principal Investigator: Simone Ferrero, Piazza della Vittoria 14, Genoa, Italy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (ACTUAL): December 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; barbed suture; uterine lower segment
• Other Study ID Numbers: BARB-LOWSEGM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No