N/A
Completed N=11
Pilot Assessment of an Auto Blood Pressure Monitor
Source: ClinicalTrials.gov NCT02258256 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. — 125.3; 85.2; 129.8; 76.9 mmHg
Summary
The purpose of the study is to help make a lower cost automatic blood pressure monitor device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood pressure monitoring is limited or not available. The study will compare this low cost device to a commercially available system used for pre-eclamptic women in many United States hospitals that the investigators will be bringing to Malawi as a part of this study.
The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use.
20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the subject and the commercially available cuff on the opposite arm. A trained research assistant and the nurse will record the blood pressure measurements and document any alarm indications made by each device. Blood pressure measurements will continue until monitoring is no longer clinically prescribed.
The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. |
125.3; 85.2; 129.8; 76.9 | — |
Eligibility Criteria
Inclusion Criteria
- Women who have been identified as at-risk for pre-eclampsia or have been diagnosed with pre-eclampsia during a visit to QECH.
- Women who have been clinically identified to benefit from continuous blood pressure monitoring.
- Women ages 18 or older.
Exclusion Criteria
- Pregnant women who have already developed eclampsia.
- Women under age 18.
Data sourced from ClinicalTrials.gov (NCT02258256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.