Validation of two oscillometric blood pressure devices for use in preeclampsia
- Conditions
- preeclampsia. toxaemia of pregnancy10026908
- Registration Number
- NL-OMON29910
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
hospital admission because of severe preeclampsia = blood pressure > 140/95 mmHg and proteinuria > 0.3 g/24 hours
Exclusion Criteria
None
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For each measurement pair the absolute value of the difference [test device] -<br /><br>[mean investigators auscultatory measurement] is calculated.<br /><br>Each measurement pair is graded as A: Difference within 5 mmHg , B: difference<br /><br>within 10 mmHg and C: difference within 15 mmHg.<br /><br>Depending on the number of readings that fall between pre-specified limits the<br /><br>device is approved yes or no. The International Protocol specifies that 33<br /><br>patients are necessary for validation.<br /><br>If the Microlife 3BTO-A and / or the OMRON meet the requirements of the<br /><br>International Protocol than use of these devices for blood pressure measurement<br /><br>can be recommended in women with moderate to severe preeclampsia. If<br /><br>requirements are not met than these devices should not be used to diagnose<br /><br>preeclampsia or to initiate treatment or adjust treatment in women with<br /><br>preeclampsia. </p><br>
- Secondary Outcome Measures
Name Time Method <p>nvt</p><br>