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Trial record 53 of 110 for:    test | ( Map: Malawi )

Pilot Assessment of an Auto Blood Pressure Monitor

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ClinicalTrials.gov Identifier: NCT02258256
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Rebecca Richards-Kortum, William Marsh Rice University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Device Feasibility
Condition Pre Eclampsia
Intervention Device: Sphygmo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Preeclamptic Women
Hide Arm/Group Description

All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device

Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Preeclamptic Women
Hide Arm/Group Description

All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device

Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
28
(20 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
11
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malawi Number Analyzed 11 participants
11
1.Primary Outcome
Title Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.
Hide Description Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants
Time Frame Measured during a single study visit, up to 24-72 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Preeclamptic Women
Hide Arm/Group Description:

All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device

Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Mean BP - Sphygmo 125.3  (31.8)
Mean Diastolic BP - Sphygmo 85.2  (29.8)
Mean Systolic BP - GE Dinamap 129.8  (24.8)
Mean Diastolic BP - GE Dinamap 76.9  (17.0)
Time Frame Adverse event data were collected over the length of the subject visit (24-72 hours).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Preeclamptic Women
Hide Arm/Group Description

All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device

Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals

All-Cause Mortality
Preeclamptic Women
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Preeclamptic Women
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Preeclamptic Women
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Rebecca Richards-Kortum
Organization: Rice 360: Institute for Global Health
Phone: 713-348-3823
Responsible Party: Rebecca Richards-Kortum, William Marsh Rice University
ClinicalTrials.gov Identifier: NCT02258256     History of Changes
Other Study ID Numbers: 14-082F-C
(COMREC) P.04/14/1548 ( Other Grant/Funding Number: Merck for Mothers: 51262 )
First Submitted: September 25, 2014
First Posted: October 7, 2014
Results First Submitted: June 24, 2016
Results First Posted: December 21, 2018
Last Update Posted: December 21, 2018