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临床试验/NCT05485844
NCT05485844已完成不适用

A Case-control Study Comparing Women With Increased Symptoms (Back Pain and Core Stability Problems) and Inter Rectus Diameter a Year After Index Pregnancy.

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Inter rectus diameter

研究概览

简要总结

The aim of this study was to compare participants with increased symptoms after index pregnancy with those reporting no change in back pain or subjective movement control and analyzed their inter rectus distance (IRD). This study is a case-control study of a cohort of women who had delivered a year earlier. We recruited participants with increased symptoms (n=14) after index pregnancy and controls (n=41) and recorded their inter rectus distance with ultrasound. A questionnaire was filled, and an ultrasound was performed two times for the study groups.

详细描述

A case control study was conducted in Helsinki University Hospital during 1.1.2018-31.3.2021.

Participants were enrolled in pregnancy screening unit. Exclusion criteria was pregnancy during the second questionnaire and body mass index over 28kg/m2. The first questionnaire was filled and the baseline width of linea alba was measured by abdominal ultrasound (US) in connection of the first early pregnancy screening during 1.1.2018-8.3.2019. The second electronic questionnaire was sent a year after the expected delivery timing. Two screening questions were used to grade the participants. Altogether 36 individuals scored at least five points reflecting to substantial increase in symptoms in screening questions in the second questionnaire after pregnancy out of which fourteen participants were randomly recruited. Another 94 individuals scored the lowest possible two points implicating no change in ones bodily experience. Three controls per case were recruited, altogether 42 controls and with one dropout the total number of controls was 41. All participants had at least 12 months from the last delivery.

Two physiotherapists conducted motor control tests and the width of linea alba was measured with a high-end ultrasound. The physiotherapists were blinded with group allocation and the previous IRD measurement. Participants did not know their own exposure status or their IRD when answering the questionnaires.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age over 18 years

排除标准

  • Body mass index (BMI) over 28 kg/m2 ( weight and height combined to report BMI in kg/m^2
  • Ongoing pregnancy during the second questionnaire, a year after the index pregnancy

结局指标

主要结局

Inter rectus diameter

时间窗: A year after index pregnancy

Ultra sound measurement of linea alba widht

次要结局

  • Sit up test(A year after index pregnancy)
  • Pelvic tilt(A year after index pregnancy)
  • One leg stance-test(A year after index pregnancy)
  • RAND36 HRQoL(A year after index pregnancy)
  • Waiter's bow(A year after index pregnancy)
  • Active straight leg test(A year after index pregnancy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaana Vironen

Associate Professor

Helsinki University Central Hospital

研究点 (1)

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