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

Not Applicable

• Conditions: Cesarean, Uterine Scar Thickness; Cesarean, Residual Myometrial Thickness; Cesarean Section; Complications, Wound, Dehiscence; Cesarean Section, Repeated; Cesarean Section Complications
• Interventions: Procedure: Double layer closure after resection uterine scar; Procedure: Single layer closure

• Registration Number: NCT03644433
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-06
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-21
• Study Start: 2018-08-23
• Study First Posted: 2018-08-23
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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
Double layer with resection	Double layer closure after resection uterine scar	Double layer closure after resection uterine scar
Single layer	Single layer closure	Single layer closure

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
residual myometrial thickness	6 weeks after cesarean	Myometrial thickness at the uterine scar by transvaginal ultrasound
Operation time	10 minute after cesarean completed	skin-to-skin operation time
Maternal infectious morbidity	six weeks after cesarean	prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.
Existence of cesarean scar defect	6 weeks 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 1 mm.
Healing ratio	6 weeks after cesarean	residual myometrial thickness \* 100 /total myometrial thickness above uterine scar
Change in hemoglobin	48 hours after cesarean	Difference in haemoglobin measured preoperatively and postoperatively 48 hours
Blood product transfusion	One week after cesarean	unite number of transfused packed erythrocyte
Length of hospitalization	One month after cesarean	Duration in days

Trial Locations

Locations (1)

Atatürk Üniversitesi araştırma Hastanesi; 🇹🇷 Erzurum, Turkey