Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

Not Applicable

Completed

• Conditions: Cesarean, Residual Myometrial Thickness; Cesarean, Uterine Scar Thickness; Cesarean Section, Repeated
• Interventions: Procedure: Single layer closure; Procedure: Double layer closure; Procedure: Doble layer closure with trimming

• Registration Number: NCT03915847
• Lead Sponsor: Ataturk University

Brief Summary

The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-15
• Study Start: 2019-04-16
• Study First Posted: 2019-04-16
• Primary Completion: 2020-04-16
• Study Completion: 2020-04-16
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single layer closure	Single layer closure	-
Double layer closure	Double layer closure	-
Doble layer closure with trimming	Doble layer closure with trimming	-

Primary Outcome Measures

Name	Time	Method
Residual myometrial thickness	6 months after cesarean	Myometrial thickness at the uterine scar by transvaginal ultrasound

Secondary Outcome Measures

Name	Time	Method
Existence of cesarean scar defect	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.
Depth of defect (niche)	6 months after cesarean	In a sagittal plane, the distance from the base lining of the endometrium to the apex
Operation time	10 minute after cesarean completed	Skin-to-skin operation time
Length of hospitalization	One month after cesarean	Duration in days
Change in hemoglobin	48 hours after cesarean	Difference in haemoglobin measured preoperatively and postoperatively 48 hours
Width of defect	6 months after cesarean	In a sagittal plane, the width at base of defect
Blood product transfusion	One week after cesarean	Unite number of transfused packed erythrocyte
Maternal infectious morbidity	Six weeks after cesarean	Prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.

Trial Locations

Locations (1)

Ataturk University Hospital; 🇹🇷 Erzurum, Turkey