Closure of Uterine Incision by Single or Double Layer Technique

Pregnancy Clinical Trial

Official title: Evaluation of Single Versus Double-layer Technique by Closure of Cesarean Uterine Incision. A Randomized Controlled Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

• NCT number: NCT02144805
• Study type: Interventional
• Source: Roskilde County Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Completion date: December 2012