Postpartum Hypertension: Remote Patient Monitoring

NCT ID: NCT03111095

Last Updated: 2025-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-06-11

Brief Summary

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The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System (mobile health) can improve patient satisfaction and quality of care provided to women experiencing complications due to high blood pressure during pregnancy.

Detailed Description

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For six weeks postpartum, patients will use Honeywell Genesis Android Touch Bluetooth System to record and submit their daily blood pressure and weight measurements to a mobile health nurse and research team. Subjects will be provided with the kit (Honeywell tablet, mobile hot spot, blood pressure cuff, and scale) at no cost. Subjects will participate in video telehealth visits at 48 hours and 7 days after discharge to help provide management for hypertension related issues.

Conditions

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Hypertension, Pregnancy-Induced

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mobile Health Participants

Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.

Group Type EXPERIMENTAL

Mobile Health

Intervention Type OTHER

Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.

Standard of Care

This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile Health

Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia diagnosed in the antenatal (primary admission for delivery of the baby (planned or due to hypertension) or postpartum period as determined by systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 on two occasions 4 hours apart.
* Gestational age at time of delivery greater than 23 weeks gestation
* Postpartum with persistent SBP greater than 140 or DBP greater than 90 on two occasions 4 hours apart (to enroll would be prior to discharge from initial postpartum hospital stay).
* Primary hospital admission for the delivery of the neonate(s).

Exclusion Criteria

* Inability to obtain informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kara Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

Clinical Assistant Professor

Locations

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UnityPoint Health- Meriter Hospital

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Hoppe KK, Thomas N, Zernick M, Zella JB, Havighurst T, Kim K, Williams M, Niu B, Lohr A, Johnson HM. Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension. Am J Obstet Gynecol. 2020 Oct;223(4):585-588. doi: 10.1016/j.ajog.2020.05.027. Epub 2020 May 19. No abstract available.

Reference Type RESULT
PMID: 32439388 (View on PubMed)

Thomas NA, Drewry A, Racine Passmore S, Assad N, Hoppe KK. Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. BMC Pregnancy Childbirth. 2021 Feb 19;21(1):153. doi: 10.1186/s12884-021-03632-9.

Reference Type RESULT
PMID: 33607957 (View on PubMed)

Hoppe KK, Williams M, Thomas N, Zella JB, Drewry A, Kim K, Havighurst T, Johnson HM. Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregnancy Hypertens. 2019 Jan;15:171-176. doi: 10.1016/j.preghy.2018.12.007. Epub 2018 Dec 31.

Reference Type RESULT
PMID: 30825917 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017-003

Identifier Type: -

Identifier Source: org_study_id

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