Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

A Prospective Pilot Study Comparing Incidence and Characteristics of Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Uterine Niche; Isthmocele; Uterine Scar Defects
• Intervention / Treatment: Procedure: Clinical and ultrasonographic assessment

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective cesarean section at ≥37 weeks of gestation

Description

Inclusion Criteria:

- Patients who underwent elective cesarean section at ≥ 37 weeks of gestation

Exclusion Criteria:

• Patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization);
• Patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy);
• Patients who had a previous diagnosis of Mullerian uterine anomalies elective cesarean for the second time or after uterine surgery;
• Patients who had evidence of PAS disorders or placenta previa.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low transverse hysterotomy closed by double-layer unidirectional barbed suture; Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by double-layer unidirectional barbed suture	Procedure: Clinical and ultrasonographic assessment; Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures
Low transverse hysterotomy closed by conventional double-layer smooth suture; Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by conventional double-layer smooth suture	Procedure: Clinical and ultrasonographic assessment; Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of uterine scar defects	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound	6 months after the cesarean section
Number of uterine scar defects	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound	12 months after the cesarean section
Number of uterine scar defects	Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound	24 months after the cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	RMT, depth, width, and length are evaluated by transvaginal ultrasound	6 months after the cesarean section
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	RMT, depth, width, and length are evaluated by transvaginal ultrasound	12 months after the cesarean section
Residual myometrium thickness (RMT), depth, width and length of uterine scar defects	RMT, depth, width, and length are evaluated by transvaginal ultrasound	24 months after the cesarean section
Number of patients with postmenstrual spotting	Number of patients with postmenstrual spotting is evaluated by medical interview	6 months after the cesarean section
Number of patients with postmenstrual spotting	Number of patients with postmenstrual spotting is evaluated by medical interview	12 months after the cesarean section
Number of patients with postmenstrual spotting	Number of patients with postmenstrual spotting is evaluated by medical interview	24 months after the cesarean section
Number of patients with dysmenorrhea	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)	6 months after the cesarean section
Number of patients with dysmenorrhea	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)	12 months after the cesarean section
Number of patients with dysmenorrhea	Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)	24 months after the cesarean section

Collaborators and Investigators

• Sponsor: Ospedale Policlinico San Martino
• Investigators: Principal Investigator: Fabio Barra, MD, IRCCS Ospedale Policlinico San Martino

Publications and helpful links

General Publications

• Agarwal S, D'Souza R, Ryu M, Maxwell C. Barbed vs conventional suture at cesarean delivery: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2021 Jun;100(6):1010-1018. doi: 10.1111/aogs.14080. Epub 2021 Feb 5.
• 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.
• Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 27, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Isthmocele; Uterine scar defects; Uterine niche
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: BARB-CSCAR

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