Closure of Uterine Incision by Single or Double Layer Technique

Zealand University Hospital

Status: Completed

Conditions: Pregnancy

Treatments: Procedure: Suturing in a single layer; Procedure: Suturing in two layer

Study type: Interventional

Funder types: Other

Identifiers

NCT02144805

SJ-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Suturing in a single layer

Active Comparator group

Description:

The technique used for single layer to close the uterine incision following cesarean sectio

Treatment:

Procedure: Suturing in a single layer

Suturing in two layer

Active Comparator group

Description:

The technique used for two layer technie to close the uterine incision following cesarean sectio

Treatment:

Procedure: Suturing in two layer