Validation of two oscillometric blood pressure devices for use in preeclampsia

Validation of two oscillometric blood pressure devices for use in preeclampsia - Validation of blood pressure devices in preeclampsia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29910

Enrollment

Registered

2006-06-01

Start date

2006-04-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preeclampsia. toxaemia of pregnancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: hospital admission because of severe preeclampsia = blood pressure > 140/95 mmHg and proteinuria > 0.3 g/24 hours

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
For each measurement pair the absolute value of the difference [test device] - [mean investigators auscultatory measurement] is calculated. Each measurement pair is graded as A: Difference within 5 mmHg , B: difference within 10 mmHg and C: difference within 15 mmHg. Depending on the number of readings that fall between pre-specified limits the device is approved yes or no. The International Protocol specifies that 33 patients are necessary for validation. If the Microlife 3BTO-A and / or the OMRON meet the requirements of the International Protocol than use of these devices for blood pressure measurement can be recommended in women with moderate to severe preeclampsia. If requirements are not met than these devices should not be used to diagnose preeclampsia or to initiate treatment or adjust treatment in women with preeclampsia.	—

Measure

Time frame

For each measurement pair the absolute value of the difference [test device] - [mean investigators auscultatory measurement] is calculated. Each measurement pair is graded as A: Difference within 5 mmHg , B: difference within 10 mmHg and C: difference within 15 mmHg. Depending on the number of readings that fall between pre-specified limits the device is approved yes or no. The International Protocol specifies that 33 patients are necessary for validation. If the Microlife 3BTO-A and / or the OMRON meet the requirements of the International Protocol than use of these devices for blood pressure measurement can be recommended in women with moderate to severe preeclampsia. If requirements are not met than these devices should not be used to diagnose preeclampsia or to initiate treatment or adjust treatment in women with preeclampsia.

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results