Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women

NCT02319174 | Completed Results

• 1 other identifier: 14-082F-B
• Study Type: interventional
• Target: 43
• 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. 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.

Conditions

Pre Eclampsia

Outcome Measures

Primary Outcomes (2)

• Accuracy of Blood Pressure Readings by Sphygmo

  Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.

  Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes

• Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.

  The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of \< 5 mmHg, \< 10 mmHg, and \< 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the \< 5 mmHg, \< 10 mmHg, and \<15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the \< 5 mmHg, \< 10 mmHg, and \<15 mmHg categories, respectively. The test device achieved a grade of (A/A) with the validation data from this study.

  Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes

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:

• Pregnant women receiving antenatal care at the UT OB/GYN clinic.
• Over the age of 18

You may not qualify if:

• Women under the age of 18
• Women unable to provide informed consent

Sponsors & Collaborators

• William Marsh Rice University: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Natarajan P, Shennan AH, Penny J, Halligan AW, de Swiet M, Anthony J. Comparison of auscultatory and oscillometric automated blood pressure monitors in the setting of preeclampsia. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1203-10. doi: 10.1016/s0002-9378(99)70109-2.

  PMID: 10561646 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

• 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

• 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

• O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, Bland M, Coats A, Atkins N. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993 Jun;11(6):677-9. doi: 10.1097/00004872-199306000-00013. No abstract available.

  PMID: 8397248 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 Kortum, PhD

  William Marsh Rice University

  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

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 18, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: November 4, 2016
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-12

Locations

US (1)