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

Ospedale Policlinico San Martino247 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

247

Conditions

Isthmocele Uterine Scar Defects Cesarean Section Complications Uterine Niche

Interventions

Clinical and ultrasonographic assessmentPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS Ospedale Policlinico San Martino

Genoa, Italy

Outcomes

Primary Outcomes

Number of uterine scar defects

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

Time frame: 6 months after the cesarean section

Number of uterine scar defects

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

Time frame: 12 months after the cesarean section

Number of uterine scar defects

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

Time frame: 24 months after the cesarean section

Secondary Outcomes

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

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

Time frame: 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

Time frame: 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

Time frame: 24 months after the cesarean section

Number of patients with postmenstrual spotting

Number of patients with postmenstrual spotting is evaluated by medical interview

Time frame: 6 months after the cesarean section

Data from ClinicalTrials.gov

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