Clinical trial NCT04482504: Balance Disorders Related to Pregnancy
Official title: Balance Disorders Related to Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Balance, Postural
Fall
Pregnancy Related
Keywords: static posturography
Fall
pregnancy
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant and non-pregnant women

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine differences of postural stability between pregnant and non-pregnant women.
timeFrame: 1 hour
Secondary outcomes:
measure: find out predisposing factors of falling during pregnancy
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
state: Slovensko
Study officials:
References: