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NCT02319174 · ClinicalTrials.gov registry record · NA
Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women
A NA study, sponsored by William Marsh Rice University.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT02319174: Completed NA study, sponsored by William Marsh Rice University.
NCT02319174 is a NA study that has completed, run by William Marsh Rice University. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02319174, a NA study, has completed, sponsored by William Marsh Rice University.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study 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. 70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at University of Texas Health Science Center Houston. Patient arm circumference will be measured with measurement tape. They will be seated upright in a comfortable chair with arm at heart level and an arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm. The cuff will be inflated and then deflated until measurement concludes. Heart rate will be measured with tactile arterial palpation.The process will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement. 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.
Primary Outcome
Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.
Interventions
- DEVICE Sphygmo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-11-04 |
| Phase | NA |
What the finished NCT02319174 record still lists
NCT02319174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Sphygmo is the first listed.
NCT02319174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02319174 about?
NCT02319174 is a clinical study titled "Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women". 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 availabl...
What is the current status of trial NCT02319174?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2015-06. Estimated completion is 2016-11-04.
What interventions are being tested in trial NCT02319174?
The interventions under investigation include: Sphygmo (DEVICE).
Who is sponsoring clinical trial NCT02319174?
This trial is sponsored by William Marsh Rice University, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02319174's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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