Cesarean Section; Dehiscence, Cesarean Wound; Dehiscence
Conditions
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.
Interventions
PROCEDUREClosure of the uterus with endometrium at the time of cesarean
Closure 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 cesarean
Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Closure of the hysterotomy at the time of primary cesarean section
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Spotting | 6 months after intervention | The rate of spotting complains of patients |
Countries
Turkey (Türkiye)
Outcome results
None listed