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OpenTrials
Completed

NCT Number: NCT02338388

Cesarean-scar Thickness and Closure Technique

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

Completed

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective cesarean section
  • Cesarean section during labor

Exclusion criteria

  • Emergency cesarean section
  • Declined to participate

Treatment and study plan

cesarean section technique

Procedure

Comparing three different types of suturing the uterus at Cesarea section

Primary outcomes

  1. cesarean scar-thickness

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Christian Bamberg

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2015
Registry last updated
Jan 15, 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.