Postpartum Hypertension: Remote Patient Monitoring

NCT03111095 | Completed Results

• 1 other identifier: 2017-003
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension, Pregnancy-Induced

Outcome Measures

Primary Outcomes (4)

• Aim 1: Number of Participants Enrolled

  A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.

  up to 3 months

• Aim 1: Number of Participants Who Completed the Study

  To assess retention, the number of participants who completed the study will be reported.

  up to 6 weeks

• Aims 2-5: Number of Participants Enrolled in 1 Year

  Aims 2-5 primary endpoint is enrollment of up to 40 participants at all times (for a total of 42 days) over one year (220 experimental and 220 matched controls for chart review).

  up to 1 year

• Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions

  Comparison of hypertension-related hospital readmissions between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with hypertensive disorders of pregnancy (HDP).

  up to 6 weeks postpartum

Secondary Outcomes (17)

• Aim 1: 6-week Hospital Readmission

  up to 6 weeks

• Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge

  up to 6 weeks

• Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits

  up to 6 weeks postpartum

• Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge

  up to 6 weeks

• Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits

  up to 6 weeks postpartum

Other Outcomes (4)

• Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.

  Up to 12 months

• Mode of Delivery

  at delivery (on average 37-40 weeks of pregnancy)

• Neonatal Birthweight

  at time of birth

Study Arms (2)

Mobile Health Participants

EXPERIMENTAL

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

Other: Mobile Health

Standard of Care

NO INTERVENTION

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

Interventions

Mobile Health 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.

Mobile Health Participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Inability to obtain informed consent

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UnityPoint Health- Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

Related Publications (3)

• 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.

  PMID: 32439388 RESULT

• 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.

  PMID: 33607957 RESULT

• 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.

  PMID: 30825917 RESULT

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Kara Hoppe, DO
• Organization: University of Wisconsin School of Medicine and Public Health

khoppe2@wisc.edu

(206) 371-4014

Study Officials

• Kara Hoppe, DO

  Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 12, 2017
• Study Start: March 23, 2017
• Primary Completion: June 8, 2018
• Study Completion: June 11, 2018
• Last Updated: August 22, 2025
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)