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临床试验/NCT04482504
NCT04482504Unknown不适用

Balance Disorders Related to Pregnancy

Comenius University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
230
试验地点
1
主要终点
To determine differences of postural stability between pregnant and non-pregnant women.

研究概览

简要总结

Primary aim of this study is to evaluate postural equilibrium and risk of falls during pregnancy by comparing static postural stability between pregnant and non-pregnant control women. Secondary aim is to find out predisposing factors of falling during pregnancy using by validated questionnaires focused on exercise activities and self-evaluation of postural stability. The investigators also determine level of vitamin D in the blood.

详细描述

Several hormonal, anatomical and physiological changes occur in the female body during pregnancy. These changes caused by pregnancy include significant weight gain, increased ligamentous laxity and spinal lordosis, decreased neuromuscular control and abdominal muscle strength, altered biomechanics and an anterior shift in the location of the centre of mass. These alteration of pregnant woman body can lead to balance problems.

Falls during pregnancy are very common. Pregnant women especially in advanced stage of pregnancy are at higher risk of falling compared to non-pregnant women. Falls during pregnancy may cause maternal injuries such as bone fractures, joint sprains, muscle strains, head injury, rupture of internal organs, abruptio placentae, rupture of the uterus and membranes and occasionally maternal death or intrauterine fetal demise. Pregnant women are hospitalized due to a fall 2,3 times more than non-pregnant reproductive-aged women.

There is few evidence in a literature about postural stability but not about risk factors, that caused stability disorders. By determination of risk factors, the investigators can reduce number of falls in pregnancy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • The investigators involve every pregnant woman in 36.-
  • week of pregnancy that attending an outpatient clinic at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic.

排除标准

  • Unwilling to participate
  • Minors (under 18 years old)
  • Musculoskeletal and neurological abnormalities
  • Unfamiliar with slovak language
  • Multiple pregnancy

结局指标

主要结局

To determine differences of postural stability between pregnant and non-pregnant women.

时间窗: 1 hour

To determine differences of postural stability between pregnant and non-pregnant women.

次要结局

  • find out predisposing factors of falling during pregnancy(1 hour)

研究者

发起方
Comenius University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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