Balance, PosturalPRSTNCT04482504
Balance Disorders Related to Pregnancy
An observational study of Balance, Postural and Fall, run by Comenius University at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Balance, Postural, Fall, Pregnancy Related
- What is being tested?
- 3 tests: Posturography, Questionnaire, vitamin D
- How many people
- 230 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant and non-pregnant women
Who may be able to join
- 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.
Who cannot join
- Unwilling to participate
- Minors (under 18 years old)
- Musculoskeletal and neurological abnormalities
- Unfamiliar with slovak language
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
Bratislava, Slovensko, 83232
About this study
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.
Read the 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.
- Conditions
- Balance, Postural, Fall, Pregnancy Related
- Being tested
- 3 tests: Posturography, Questionnaire, vitamin D
- Keywords
- static posturography, Fall, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine differences of postural stability between pregnant and non-pregnant women.
To determine differences of postural stability between pregnant and non-pregnant women.
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Oct 2019
- Primary completion31 May 2020
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance, PosturalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482504
- Sponsor's protocol ID
- EC/099/2019/UNBRuzinov
- Acronym
- PRST
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet setup.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Disorders Related to Pregnancy
- ClinicalTrials.gov ID
- NCT04482504
- Acronym / sponsor ID
- PRST / EC/099/2019/UNBRuzinov
- Conditions
- Balance, Postural, Fall, Pregnancy Related
- Keywords
- static posturography, Fall, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant women | – | Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D200 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 |
| non-pregnant women | – | Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D30 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant and non-pregnant women
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Unwilling to participate
- Minors (under 18 years old)
- Musculoskeletal and neurological abnormalities
- Unfamiliar with slovak language
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 tests: Posturography, Questionnaire, vitamin DPosturography 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. | Diagnostic test | healthy pregnant women, non-pregnant women |
Primary outcome
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.
1 secondary outcome
find out predisposing factors of falling during pregnancy
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Undecided. Not yet setup.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Balance, Postural and Fall, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine differences of postural stability between pregnant and non-pregnant women. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.