Closure of Uterine Incision by Single or Double Layer Technique

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Procedure: Suturing in two layer; Procedure: Suturing in a single layer

• Registration Number: NCT02144805
• Lead Sponsor: Zealand University Hospital

Brief Summary

The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Detailed Description

Objective: To compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Design:Follow-up by ultra sound of a randomised controlled trial. Surgical technique was blinded for the investigator.

Setting: An obstetric department in a tertiary referral hospital, 2008-2013. Participants: Healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques.

Intervention: A modified version of the Misgav-Ladach surgical technique was used. The women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum.

Main outcome measure: Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

Inclusion Criteria

• Women submitted to cesarean sectio

Exclusion Criteria

• Exclusion criteria were: Former uterine operations such as myomectomy or surgery resulting in entering the cavity, fibroids located in the cervix or the cervicalcorporal border, inflammatory bowel disease, SLE, rheumatoid arthritis, IDDM, re-operations after inclusion or the cesarean section and more than three additional single sutures for hemostasis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suturing in two layer	Suturing in two layer	The technique used for two layer technie to close the uterine incision following cesarean sectio
Suturing in a single layer	Suturing in a single layer	The technique used for single layer to close the uterine incision following cesarean sectio

Primary Outcome Measures

Name	Time	Method
Myometrial thickness	5 months	Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology; 🇩🇰 Roskilde, Denmark