Clinical Trials Directory

Trials / Completed

CompletedNCT02144805

Closure of Uterine Incision by Single or Double Layer Technique

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
77 (actual)
Sponsor
Zealand University Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESuturing in a single layerThe procedure define the use of one single suture for closure of the uterine incision following cesarean section.
PROCEDURESuturing in two layerThe procedure define the use of two sutures for closing the uterine incision following cesarean section

Timeline

Start date
2008-01-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2014-05-22
Last updated
2015-05-06

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02144805. Inclusion in this directory is not an endorsement.