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

NCT ID: NCT02319174

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-11-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pre Eclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Sphygmo

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.

Group Type EXPERIMENTAL

Sphygmo

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

William Marsh Rice University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Richards-Kortum

Stanley C. Moore Professor of Bioengineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca R Kortum, PhD

Role: PRINCIPAL_INVESTIGATOR

William Marsh Rice University

Locations

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University of Texas Health Science Center Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10561646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21151680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11213110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21545480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20367507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8397248 (View on PubMed)

Other Identifiers

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14-082F-B

Identifier Type: -

Identifier Source: org_study_id