Pilot Assessment of an Auto Blood Pressure Monitor

NCT02258256 | Completed Results

• 2 other identifiers: 14-082F-C(COMREC) P.04/14/1548
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Eclampsia

Outcome Measures

Primary Outcomes (1)

• Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.

  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

  Measured during a single study visit, up to 24-72 hours.

Study Arms (1)

Sphygmo

EXPERIMENTAL

All subjects will have 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

Device: Sphygmo

Interventions

Sphygmo DEVICE

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

Sphygmo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women who have already developed eclampsia.
• Women under age 18.

Sponsors & Collaborators

• William Marsh Rice University: lead
• University of Malawi: collaborator

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Related Publications (5)

• Magee LA, Abalos E, von Dadelszen P, Sibai B, Easterling T, Walkinshaw S; CHIPS Study Group. How to manage hypertension in pregnancy effectively. Br J Clin Pharmacol. 2011 Sep;72(3):394-401. doi: 10.1111/j.1365-2125.2011.04002.x.

  PMID: 21545480 BACKGROUND

• Wagner LK. Diagnosis and management of preeclampsia. Am Fam Physician. 2004 Dec 15;70(12):2317-24.

  PMID: 15617295 BACKGROUND

• De Greeff A, Ghosh D, Anthony J, Shennan A. Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia. Hypertens Pregnancy. 2010 Jan;29(2):198-205. doi: 10.3109/10641950902968650.

  PMID: 20367507 BACKGROUND

• Turner JA. Diagnosis and management of pre-eclampsia: an update. Int J Womens Health. 2010 Sep 30;2:327-37. doi: 10.2147/IJWH.S8550.

  PMID: 21151680 BACKGROUND

• Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. doi: 10.1016/S0140-6736(00)03599-6.

  PMID: 11213110 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Rebecca Richards-Kortum
• Organization: Rice 360: Institute for Global Health

rkortum@rice.edu

713-348-3823

Study Officials

• Rebecca R Richards-Kortum, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

• Ronald Mataya, MD

  University of Malawi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stanley C. Moore Professor of Bioengineering

Model Details: Pregnant women will have their blood pressure measured by both the experimental device (Sphygmo ) and the gold-standard, commercial device (GE Dinamap Procare).

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 7, 2014
• Study Start: March 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 10, 2021
• Results First Posted: December 21, 2018

Record last verified: 2021-08

Locations

MA (1)