Completed

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

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What is being tested

cesarean section technique

Procedure
Who is being recruted

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorChristian Bamberg
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleLongitudinal Transvaginal Ultrasound Evaluation of Cesarean-scar Thickness in the First Two Years After Single- or Double-layer Uterotomy Closure: a Prospective Randomized Study
NCT02338388
Principal SponsorChristian Bamberg
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

435 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Elective cesarean section

Cesarean section during labor

2 exclusion criteria prevent from participating
Emergency cesarean section

Declined to participate

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The first layer was continuous and unlocked and a second, continuous non-locking imbricating layer was applied over the first suture.

Group II

Active Comparator

Group III

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers