Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section

Study Overview
=================
Brief Summary
-----------------
We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.

Official Title
-----------------
Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing

Conditions
-----------------
Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness, Cesarean Section Complications, Cesarean Section; Complications, Wound, Dehiscence

Intervention / Treatment
-----------------
* Procedure: Single layer closure
* Procedure: Double layer closure after resection uterine scar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous two or three cesarean gestational weeks >=36 weeks Exclusion Criteria: risk of obstetric haemorrhage suspicion or diagnosis placenta previa or accrete syndrome chorioamnionitis uterine myoma in the anterior uterine segment hysterotomy other than lower segment uterine incision at previous cesarean

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Single layer<br>Single layer closure | Procedure: Single layer closure<br>* Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.<br>|
| Active Comparator: Double layer with resection<br>Double layer closure after resection uterine scar | Procedure: Double layer closure after resection uterine scar<br>* Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual myometrial thickness | Myometrial thickness at the uterine scar by transvaginal ultrasound | 6 months after cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual myometrial thickness | Myometrial thickness at the uterine scar by transvaginal ultrasound | 6 weeks after cesarean | 
| Healing ratio | residual myometrial thickness * 100 /total myometrial thickness above uterine scar | 6 months after cesarean | 
| Healing ratio | residual myometrial thickness * 100 /total myometrial thickness above uterine scar | 6 weeks after cesarean | 
| Existence of cesarean scar defect | The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 1 mm. | 6 months after cesarean | 
| Existence of cesarean scar defect | The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 1 mm. | 6 weeks after cesarean | 
| Operation time | skin-to-skin operation time | 10 minute after cesarean completed | 
| Change in hemoglobin | Difference in haemoglobin measured preoperatively and postoperatively 48 hours | 48 hours after cesarean | 
| Blood product transfusion | unite number of transfused packed erythrocyte | One week after cesarean | 
| Maternal infectious morbidity | prevalence of postpartum endometritis, skin wound dehiscence and post operative fever. | six weeks after cesarean | 
| Length of hospitalization | Duration in days | One month after cesarean |