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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04825821

Enrollment

247

Registered

2021-04-01

Start date

2019-03-01

Completion date

2022-09-30

Last updated

2022-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Uterine scar defects, Uterine niche, Isthmocele

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.

Interventions

PROCEDUREClinical and ultrasonographic assessment

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026