Lower Uterine Segment Following a Cesarean Section With Barbed Suture

Cesarean Section Complications Clinical Trial

— BARB-LOWSEGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166174
• Other study ID #: BARB-LOWSEGM
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2021
• Source: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Cesarean Wound; Dehiscence

Intervention

Procedure:
• Transvaginal ultrasound in the third trimester pregnancy
Ultrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation)

Locations

Country	Name	City	State
Italy	Piazza della Vittoria 14	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonographic measure of lower uterine segment thickness	Measure of lower uterine thickness (mm) at transvaginal ultrasound	34-38 weeks following study enrollment