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Completed

NCT Number: NCT04825821

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.

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Key information

Conditions

Isthmocele Cesarean Section Complications Uterine Niche Uterine Scar Defects

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical and ultrasonographic assessment

Procedure

Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures

Primary outcomes

  1. Number of uterine scar defects

    Time frame: 6 months after the cesarean section

    Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound

  2. Number of uterine scar defects

    Time frame: 12 months after the cesarean section

    Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound

  3. Number of uterine scar defects

    Time frame: 24 months after the cesarean section

    Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound

Secondary outcomes

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

    Time frame: 6 months after the cesarean section

    RMT, depth, width, and length are evaluated by transvaginal ultrasound

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

    Time frame: 12 months after the cesarean section

    RMT, depth, width, and length are evaluated by transvaginal ultrasound

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

    Time frame: 24 months after the cesarean section

    RMT, depth, width, and length are evaluated by transvaginal ultrasound

  4. Number of patients with postmenstrual spotting

    Time frame: 6 months after the cesarean section

    Number of patients with postmenstrual spotting is evaluated by medical interview

  5. Number of patients with postmenstrual spotting

    Time frame: 12 months after the cesarean section

    Number of patients with postmenstrual spotting is evaluated by medical interview

  6. Number of patients with postmenstrual spotting

    Time frame: 24 months after the cesarean section

    Number of patients with postmenstrual spotting is evaluated by medical interview

  7. Number of patients with dysmenorrhea

    Time frame: 6 months after the cesarean section

    Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)

  8. Number of patients with dysmenorrhea

    Time frame: 12 months after the cesarean section

    Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)

  9. Number of patients with dysmenorrhea

    Time frame: 24 months after the cesarean section

    Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale)

Sponsors and collaborators

Lead sponsor

Ospedale Policlinico San Martino

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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