Postpartum Hypertension: Remote Patient Monitoring

Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pregnancy-Induced
• Intervention / Treatment: Other: Mobile Health

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • UnityPoint Health- Meriter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Health Participants; Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.	Other: 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.
No Intervention: Standard of Care; This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1: 6-week Hospital Readmission		up to 6 weeks
Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge	Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)	up to 6 weeks
Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits	Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).	up to 6 weeks postpartum
Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge	Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).	up to 6 weeks
Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits	Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).	up to 6 weeks postpartum
Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery	Comparison of number of participants with at least one blood pressure review within 10 days of delivery between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).	up to 10 days of delivery
Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes	Comparison of number of participants on antihypertensive treatments between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).	up to 6 weeks postpartum
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum		Admission to delivery (up to 96 hours)
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum		Admission to delivery (up to 96 hours)
Aims 2-5: Systolic Blood Pressure at Discharge		Up to 96 hours postpartum
Aims 2-5: Diastolic Blood Pressure at Discharge		Up to 96 hours postpartum
Aims 2-5: Medication at Discharge		up to 96 hours postpartum
Aims 2-5: Postpartum Day of Discharge		up to 4.5 days
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use		up to 4 days post-partum
Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery		first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy)
Self-Administered Questionnaire Satisfaction Survey Scores	In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of mean scores (1-5) are reported here.	up to 6 weeks postpartum
Participant Counts for Relevant SAQ Satisfaction Survey Questions	In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of questions with participant counts is reported here.	up to 6 weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.	Cost effectiveness modeling will be performed to determine whether it is cost effective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy.	Up to 12 months
Mode of Delivery		at delivery (on average 37-40 weeks of pregnancy)
Neonatal Birthweight		at time of birth
Neonatal Intensive Care Unit Admissions		at birth

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Kara Hoppe, DO, Clinical Assistant Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): June 8, 2018
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Hypertension
• Other Study ID Numbers: 2017-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No