Balance Disorders Related to Pregnancy (PRST)

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Related; Fall; Balance, Postural
• Intervention / Treatment: Diagnostic test: 3 tests: Posturography, Questionnaire, vitamin D

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.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Slovakia
  • Slovensko
    • Bratislava, Slovensko, Slovakia, 83232
      • 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant and non-pregnant women

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy pregnant women; 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: Unwilling to participate; Minors (under 18 years old) e) Unfamiliar with slovak language f) Multiple pregnancy g) Musculoskeletal and neurological abnormalities	Diagnostic test: 3 tests: Posturography, Questionnaire, vitamin D; Posturography platform Kistler 9281B Questionnaire focused on exercise activities and self-evaluation of postural stability The investigators also determine level of vitamin D in the blood.
non-pregnant women; 30 non-pregnant healthy control women The investigators involve every healthy non-pregnant woman. Exclusion criteria: Unwilling to participate; Minors (under 18 years old) e) Unfamiliar with slovak language f) Pregnancy g) Musculoskeletal and neurological abnormalities	Diagnostic test: 3 tests: Posturography, Questionnaire, vitamin D; Posturography platform Kistler 9281B Questionnaire focused on exercise activities and self-evaluation of postural stability The investigators also determine level of vitamin D in the blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine differences of postural stability between pregnant and non-pregnant women.	To determine differences of postural stability between pregnant and non-pregnant women.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
find out predisposing factors of falling during pregnancy	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.	1 hour

Collaborators and Investigators

• Sponsor: Comenius University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 18, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pregnancy; Fall; static posturography
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: EC/099/2019/UNBRuzinov

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not yet setup.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No