Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section; Dehiscence; Cesarean Wound; Dehiscence
• Interventions: Procedure: Closure of the uterus without endometrium at the time of cesarean; Procedure: Closure of the uterus with endometrium at the time of cesarean

• Registration Number: NCT04198324
• Lead Sponsor: Kocaeli University

Brief Summary

This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.

Detailed Description

Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2019-12-16
• Status Verified: 2020-12
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

• Term pregnancy (≥37 weeks of gestation)
• Singleton pregnancy
• Primary cesarean

Exclusion Criteria

• Previous cesarean section
• Previous uterine surgery
• Multiple gestations
• Mullerian anomalies
• Active labor
• Placenta previa/accreta

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-endometrial uterine closure	Closure of the uterus without endometrium at the time of cesarean	The uterus will be sewn with locked sutures that pass through myometrium without endometrium.
Entire fold uterine closure	Closure of the uterus with endometrium at the time of cesarean	The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium.

Primary Outcome Measures

Name	Time	Method
Number of patients with isthmocele six month after cesarean section	6 months after intervention	Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography
Mean myometrium thickness	6 months after intervention	Myometrial thickness measured at incision site with transvaginal ultrasonography

Secondary Outcome Measures

Name	Time	Method
Spotting	6 months after intervention	The rate of spotting complains of patients

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey