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Completed

NCT Number: NCT02144805

Closure of Uterine Incision by Single or Double Layer Technique

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.

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Key information

Conditions

Pregnancy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology

Roskilde, 4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suturing in a single layer

Procedure

The procedure define the use of one single suture for closure of the uterine incision following cesarean section.

Suturing in two layer

Procedure

The procedure define the use of two sutures for closing the uterine incision following cesarean section

Primary outcomes

  1. Myometrial thickness

    Time frame: 5 months

    Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Region Zealand

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 22, 2014
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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