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Balance Disorders Related to Pregnancy (PRST)

C

Comenius University

Status

Unknown

Conditions

Balance, Postural
Pregnancy Related
Fall

Treatments

Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D

Study type

Observational

Funder types

Other

Identifiers

NCT04482504
EC/099/2019/UNBRuzinov

Details and patient eligibility

About

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.

Full 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.

Enrollment

230 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • The investigators involve every pregnant woman in 36.-38. 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

Trial design

230 participants in 2 patient groups

healthy pregnant women
Description:
200 healthy pregnant women in 36.-38. Week of pregnancy. The investigators involve every healthy pregnant woman in 36.-38. week of pregnancy. Exclusion criteria: 1. Unwilling to participate 2. Minors (under 18 years old) e) Unfamiliar with slovak language f) Multiple pregnancy g) Musculoskeletal and neurological abnormalities
Treatment:
Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D
non-pregnant women
Description:
30 non-pregnant healthy control women The investigators involve every healthy non-pregnant woman. Exclusion criteria: 1. Unwilling to participate 2. Minors (under 18 years old) e) Unfamiliar with slovak language f) Pregnancy g) Musculoskeletal and neurological abnormalities
Treatment:
Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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