Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section, Repeated; Cesarean, Uterine Scar Thickness; Cesarean, Residual Myometrial Thickness
• Intervention / Treatment: Procedure: Single layer closure; Procedure: Double layer closure; Procedure: Doble layer closure with trimming

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey
    • Ataturk University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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
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 2 mm.	6 months after cesarean
Width of defect	In a sagittal plane, the width at base of defect	6 months after cesarean
Depth of defect (niche)	In a sagittal plane, the distance from the base lining of the endometrium to the apex	6 months 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

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2019
• Primary Completion (ACTUAL): April 16, 2020
• Study Completion (ACTUAL): April 16, 2020

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ATA35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No