Evaluation of Cesarean Scar After Three Different Uterine Closure Technis
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|ClinicalTrials.gov Identifier: NCT03915847|
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : May 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section, Repeated Cesarean, Uterine Scar Thickness Cesarean, Residual Myometrial Thickness||Procedure: Single layer closure Procedure: Double layer closure Procedure: Doble layer closure with trimming||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial|
|Actual Study Start Date :||April 16, 2019|
|Actual Primary Completion Date :||April 16, 2020|
|Actual Study Completion Date :||April 16, 2020|
|Active Comparator: Single layer closure||
Procedure: Single layer closure
Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.
|Active Comparator: Double layer closure||
Procedure: Double layer closure
The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
|Active Comparator: Doble layer closure with trimming||
Procedure: Doble layer closure with trimming
Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
- Residual myometrial thickness [ Time Frame: 6 months after cesarean ]Myometrial thickness at the uterine scar by transvaginal ultrasound
- Existence of cesarean scar defect [ Time Frame: 6 months after cesarean ]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 2 mm.
- Width of defect [ Time Frame: 6 months after cesarean ]In a sagittal plane, the width at base of defect
- Depth of defect (niche) [ Time Frame: 6 months after cesarean ]In a sagittal plane, the distance from the base lining of the endometrium to the apex
- Operation time [ Time Frame: 10 minute after cesarean completed ]Skin-to-skin operation time
- Change in hemoglobin [ Time Frame: 48 hours after cesarean ]Difference in haemoglobin measured preoperatively and postoperatively 48 hours
- Blood product transfusion [ Time Frame: One week after cesarean ]Unite number of transfused packed erythrocyte
- Maternal infectious morbidity [ Time Frame: Six weeks after cesarean ]Prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.
- Length of hospitalization [ Time Frame: One month after cesarean ]Duration in days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915847
|Ataturk University Hospital|