Balance Disorders Related to Pregnancy

• Conditions: Fall; Balance, Postural; Pregnancy Related

• Registration Number: NCT04482504
• Lead Sponsor: Comenius University

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-05-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-18
• Study First Posted: 2020-07-22
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine differences of postural stability between pregnant and non-pregnant women.	1 hour	To determine differences of postural stability between pregnant and non-pregnant women.

Secondary Outcome Measures

Name	Time	Method
find out predisposing factors of falling during pregnancy	1 hour	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.

Trial Locations

Locations (1)

2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic; 🇸🇰 Bratislava, Slovensko, Slovakia