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临床试验/NCT02338388
NCT02338388已完成不适用

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

Christian Bamberg0 个研究点目标入组 435 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
435
主要终点
cesarean scar-thickness

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Elective cesarean section
  • Cesarean section during labor

排除标准

  • Emergency cesarean section
  • Declined to participate

结局指标

主要结局

cesarean scar-thickness

时间窗: 24 months

次要结局

未报告次要终点

研究者

发起方
Christian Bamberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christian Bamberg

Christian Bamberg, MD, PhD

Charite University, Berlin, Germany

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