Clinical Trial: Pilot Assessment of an Automatic Blood Pressure Monitor for Diagnosis and Management of Pre-eclampsia in a Low-resource Hospital
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Pilot Clinical Assessment of the Diagnostic Capability, Usability, and Function of an Automatic Blood Pressure Monitor for Use in the Diagnosis and Management of Pre-eclampsia
Brief 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.
Detailed Summary:
The research team at Rice University has developed Sphygmo, an automatic blood pressure monitor to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current blood pressure monitoring is limited. This study aims to evaluate the capabilities of the device in the setting for which it was designed - a low-resource hospital.
This study will compare the Sphygmo device to a commercially available automatic blood pressure monitor that is used in pre-eclamptic women. The main objective of this study is to determine whether the Sphygmo device correctly identifies instances where blood pressure measurement meets the diagnostic criteria for mild or severe pre-eclampsia during monitoring of at-risk mothers. Additionally, this study aims to understand the frequency and type of any complications associated with use of the Sphygmo in a resource-limited clinical setting.
The study will include 20 eligible and consenting women at QECH who are clinically identified as at-risk for pre-eclampsia or have already been diagnosed with pre-eclampsia by their doctors. All participants will undergo the same protocol (monitoring with both Sphygmo and the commercially available device). First, a nurse will fit a Sphygmo device cuff on one arm of the subject and the commercially available device cuff on the opposite arm. A trained research assistant will be continuously on hand to assist the nurse in the device setup and record the blood pressure measurements and any alarm indications made by each device. Blood pressure measurements by Sphygmo and the commercially available device will continue until monitoring is no longer clinically prescribed. In addition, blood pressure will be taken via clinical ausculatory measurement with a stethescope and aneroid gauge at regular intervals. T
Sponsor: William Marsh Rice University
Current Primary Outcome: Accuracy of blood pressure [ Time Frame: measured at the single study visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: William Marsh Rice University
Dates:
Date Received: September 25, 2014
Date Started: August 2015
Date Completion: May 2017
Last Updated: April 11, 2016
Last Verified: April 2016
