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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02144805
Enrollment
77
Registered
2014-05-22
Start date
2008-01-31
Completion date
2012-12-31
Last updated
2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Brief 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.

Interventions

PROCEDURESuturing in a single layer

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

PROCEDURESuturing in two layer

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

Sponsors

Region Zealand
CollaboratorOTHER
Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Women submitted to cesarean sectio

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Myometrial thickness5 monthsThickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026