Pregnant Women
Conditions
Keywords
balance, postural, fall risk, anthropometrics, blood pressure, SpO2, heart rate, heart rate variability, stance width
Brief summary
Determine balance changes during pregnancy
Detailed description
The subjects will be tested at enrollment and during weeks 20, 24, 28, 32, 36, 40 of their pregnancy, as well every 4 weeks postpartum up to 6 months. The following protocol will be used: 1. Subjects will also be asked to answer a short health questionnaire. 2. The following data will be recorded each time: height, minimum stance width, circumference measurements of the chest, abdomen, hip and each thigh as well as a supine fundal height. A full body side-profile photo was also taken to determine the curvature of the spine. 3. A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity. 4. In a seated position, the following measurements will be recorded: 1-minute heart rate variability (HRV) with paced breathing, temporal scan body temperature, respiration rate, heart rate, blood pressure and SpO2 (these last three will be measured bilaterally). 5. Subject will undergo posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: four 30 s tests in the following conditions: eyes open on a rigid surface (NSEO), eyes closed on a rigid surface (NSEC), eyes open on a compliant surface (PSEO), and eyes closed on a compliant surface (PSEC). 6. At the end of the posturography testing, heart rate, blood pressure and SpO2 will be re-measured bilaterally in the standing and then seated positions, as will be the seated HRV.
Interventions
DIAGNOSTIC_TESTPosturography Evaluation
Posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, with eyes open or closed
DIAGNOSTIC_TESTAnthropometrics
measurement of height, minimum stance width (feet together or as close as they can be), circumference of the torso at the breast level, of the abdomen, of the hip, and of each thigh, and supine fundal height
DIAGNOSTIC_TESTVitals
measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability
OTHERHealth and daily activity questionnaires
one time general health questionnaire as well as session questionnaires asking the subjects if they have fallen since their last testing session and how comfortable they are in doing daily activities
Sponsors
Caps Research Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* healthy women less than 20 weeks pregnant
Exclusion criteria
* women affected by any pathology and/or more than 20 weeks pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability Score | From enrollment to 6 month post partum | The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center of Pressure (CoP) coordinates | From enrollment to 6 month post partum | The CoP coordinates (standard posturography measurements) will be also used to investigate how balance changes during pregnancy and how it correlates to anthropometrics, vitals and questionnaires |
Countries
United States
Outcome results
None listed