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

NCT04825821 | Completed

• 1 other identifier: BARB-CSCAR
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Isthmocele; Uterine Scar Defects; Cesarean Section Complications; Uterine Niche

Keywords

Uterine scar defects; Uterine niche; Isthmocele

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Residual myometrium thickness (RMT), depth, width and length of uterine scar defects

  6 months after the cesarean section

• Residual myometrium thickness (RMT), depth, width and length of uterine scar defects

  12 months after the cesarean section

• Residual myometrium thickness (RMT), depth, width and length of uterine scar defects

  24 months after the cesarean section

• Number of patients with postmenstrual spotting

  6 months after the cesarean section

• Number of patients with postmenstrual spotting

  12 months after the cesarean section

Study Arms (2)

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

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

Interventions

Clinical and ultrasonographic assessment PROCEDURE

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; Low transverse hysterotomy closed by double-layer unidirectional barbed suture

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Location

Related Publications (3)

• 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.

  PMID: 33404082 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

• 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.

  PMID: 29536581 BACKGROUND

Study Officials

• Fabio Barra, MD

  IRCCS Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 1, 2021
• Study Start: March 1, 2019
• Primary Completion: July 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

IT (1)