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Clinical Trials/NCT04482504
NCT04482504
Unknown
Not Applicable

Balance Disorders Related to Pregnancy

Comenius University1 site in 1 country230 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Balance, Postural
Sponsor
Comenius University
Enrollment
230
Locations
1
Primary Endpoint
To determine differences of postural stability between pregnant and non-pregnant women.
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Comenius University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 hour

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

Secondary Outcomes

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

Study Sites (1)

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