Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Kocaeli University

Status: Completed

Conditions: Cesarean Section; Dehiscence; Cesarean Wound; Dehiscence

Treatments: Procedure: Closure of the uterus without endometrium at the time of cesarean; Procedure: Closure of the uterus with endometrium at the time of cesarean

Study type: Interventional

Funder types: Other

Identifiers

NCT04198324

KIA 2019/94

Details and patient eligibility

About

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

Full 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.

Enrollment: 170 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Entire fold uterine closure

Active Comparator group

Description:

The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium.

Treatment:

Procedure: Closure of the uterus with endometrium at the time of cesarean

Non-endometrial uterine closure

Experimental group

Description:

The uterus will be sewn with locked sutures that pass through myometrium without endometrium.

Treatment:

Procedure: Closure of the uterus without endometrium at the time of cesarean