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Cesarean-scar Thickness and Closure Technique

Longitudinal Transvaginal Ultrasound Evaluation of Cesarean-scar Thickness in the First Two Years After Single- or Double-layer Uterotomy Closure: a Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02338388
Enrollment
435
Registered
2015-01-14
Start date
2012-01-31
Completion date
2014-08-31
Last updated
2015-01-15

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

Conditions

Uterine Scar Remodeling

Brief summary

The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.

Detailed description

The aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after Cesarean delivery. The women were included at their booking visit for an elective CD or during labor before an nonemergent CD. They were randomly assigned for three different uterotomy suture techniques: The uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer. Six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a GE E8 system equipped with a 5-9 MHz transducer (GE Healthcare, Milwaukee, WI). The measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.

Interventions

PROCEDUREcesarean section technique

Comparing three different types of suturing the uterus at Cesarea section

Sponsors

Christian Bamberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Elective cesarean section * Cesarean section during labor

Exclusion criteria

* Emergency cesarean section * Declined to participate

Design outcomes

Primary

MeasureTime frame
cesarean scar-thickness24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026