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Lower Uterine Segment Following a Cesarean Section With Barbed Suture

NCT ID: NCT05166174

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Cesarean Wound; Dehiscence Cesarean Section Complications

Keywords

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barbed suture uterine lower segment cesarean section

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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").

Transvaginal ultrasound in the third trimester pregnancy

Intervention Type PROCEDURE

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.

Transvaginal ultrasound in the third trimester pregnancy

Intervention Type PROCEDURE

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

Interventions

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Transvaginal ultrasound in the third trimester pregnancy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

OTHER

Sponsor Role lead

Responsible Party

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Simone Ferrero

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Ferrero

Role: PRINCIPAL_INVESTIGATOR

Piazza della Vittoria 14, Genoa, Italy

Locations

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Piazza della Vittoria 14

Genoa, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 20500938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34146146 (View on PubMed)

Other Identifiers

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BARB-LOWSEGM

Identifier Type: -

Identifier Source: org_study_id