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

Pre Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319174
• Other study ID #: 14-082F-B
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 4, 2016

Study information

• Verified date: December 2018
• Source: William Marsh Rice University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The research team has developed 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 monitoring is limited. This study aims to evaluate the accuracy of the device's blood pressure measurements in pregnant and pre-eclamptic women. This device must be evaluated with the above described population because blood pressure measurement devices are known to perform differently in pregnant and pre-eclamptic women than in normal healthy adults.

This study will take place at the University of Texas Health Science Center (UTHSC) where up to 70 subjects will be recruited to participate during their regularly scheduled antenatal care checkups.

1. The Patient arm circumference will be measured with measurement tape.

2. The Patient will be seated upright in a comfortable chair with arm at heart level.

3. An arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm of the patient over the brachial artery.

4. Cuff will be inflated to ~200 mmHg and then deflated until measurement concludes.

5. Heart rate will be measured with Tactile Arterial Palpation.

6. Steps 3-4 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 4, 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women receiving antenatal care at the UT OB/GYN clinic.

• Over the age of 18

Exclusion Criteria:

• Women under the age of 18

• Women unable to provide informed consent

Related Conditions & MeSH terms

• Eclampsia
• Pre Eclampsia
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
William Marsh Rice University	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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