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This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entire fold uterine closure | Active Comparator | The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium. |
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| Non-endometrial uterine closure | Experimental | The uterus will be sewn with locked sutures that pass through myometrium without endometrium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closure of the uterus with endometrium at the time of cesarean | Procedure | Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with isthmocele six month after cesarean section | Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography | 6 months after intervention |
| Mean myometrium thickness | Myometrial thickness measured at incision site with transvaginal ultrasonography | 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Spotting | The rate of spotting complains of patients | 6 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Affiliation | Role |
|---|---|---|
| Åžener Gezer, M.D | Kocaeli University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University | Kocaeli | 41380 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23996650 | Background | Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199. |
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Closure of the hysterotomy at the time of primary cesarean section
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| Closure of the uterus without endometrium at the time of cesarean | Procedure | Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium. |
|