Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

Conditions
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Cesarean Section; Dehiscence, Cesarean Wound; Dehiscence

Intervention / Treatment
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* Procedure: Closure of the uterus with endometrium at the time of cesarean
* Procedure: Closure of the uterus without endometrium at the time of cesarean


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Closure of the hysterotomy at the time of primary cesarean section
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Entire fold uterine closure<br>The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium. | Procedure: Closure of the uterus with endometrium at the time of cesarean<br>* Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.<br>|
| Experimental: Non-endometrial uterine closure<br>The uterus will be sewn with locked sutures that pass through myometrium without endometrium. | Procedure: Closure of the uterus without endometrium at the time of cesarean<br>* Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spotting | The rate of spotting complains of patients | 6 months after intervention |