Clinical Trials Directory

Trials / Completed

CompletedNCT04198324

Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
170 (actual)
Sponsor
Kocaeli University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREClosure of the uterus with endometrium at the time of cesareanClosure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.
PROCEDUREClosure of the uterus without endometrium at the time of cesareanClosure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.

Timeline

Start date
2019-12-16
Primary completion
2020-12-14
Completion
2020-12-14
First posted
2019-12-13
Last updated
2020-12-16

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04198324. Inclusion in this directory is not an endorsement.