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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raşit Özler, Md; Phone Number: 00905465252595; Email: m.rasitozler@gmail.com
• Study Contact Backup: Name: ragıp a al, md; Phone Number: 00904423447649; Email: atakanal@gmail.com

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Recruiting
    • Atatürk Üniversitesi Araştırma Hastanesi
    • Contact: Raşit Özler, Md

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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Single layer; Single layer closure	Procedure: Single layer closure; Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.
Active Comparator: Double layer with resection; Double layer closure after resection uterine scar	Procedure: Double layer closure after resection uterine scar; 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.

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
Change in hemoglobin	Difference in haemoglobin measured preoperatively and postoperatively 48 hours	48 hours after cesarean
Length of hospitalization	Duration in days	One month after cesarean
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
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

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: B.30.2.ATA.0.01.00/4

Drug and device information, study documents

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