NCT04482504

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

July 18, 2020

Last Update Submit

July 22, 2020

Conditions

Balance, PosturalFallPregnancy Related

Keywords

static posturographyFallpregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • find out predisposing factors of falling during pregnancy

    1 hour

Study Arms (2)

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: 1. Unwilling to participate 2. 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

non-pregnant women

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

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

Interventions

3 tests: Posturography, Questionnaire, vitamin DDIAGNOSTIC_TEST

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.

healthy pregnant womennon-pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregrancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant and non-pregnant women

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic

Bratislava, Slovensko, 83232, Slovakia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 22, 2020

Study Start

October 1, 2019

Primary Completion

May 31, 2020

Study Completion

September 30, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

SL(1)