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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144805
• Other study ID #: SJ-29
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: May 5, 2015
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Roskilde County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Procedure:
• Suturing in a single layer
The procedure define the use of one single suture for closure of the uterine incision following cesarean section.
• Suturing in two layer
The procedure define the use of two sutures for closing the uterine incision following cesarean section

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynecology	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Roskilde County Hospital	Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myometrial thickness	Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound	5 months	No