Hypertension, Pregnancy-InducedNCT03111095

Postpartum Hypertension: Remote Patient Monitoring

A study testing Mobile Health in people with Hypertension, Pregnancy-Induced, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Hypertension, Pregnancy-Induced
What is being tested?: Mobile Health
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 428 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2017to 11 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

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).

Who cannot join

Inability to obtain informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

UnityPoint Health- Meriter Hospital
Madison, Wisconsin, 53715

Other trials in United States

About this study

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

Read the 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.

Conditions: Hypertension, Pregnancy-Induced
Being tested: Mobile Health
Medical subject headings: Hypertension, Pregnancy-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile HealthOther
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.

Study groups in NCT03111095
Study group	Role	What they receive
Mobile Health Participants	Experimental	Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Aim 1: Number of Participants Enrolled
A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: up to 6 weeks postpartum

Secondary outcomes (17)

Aim 1: 6-week Hospital Readmission
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: up to 6 weeks postpartum
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
Measured: Admission to delivery (up to 96 hours)
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
Measured: Admission to delivery (up to 96 hours)
Aims 2-5: Systolic Blood Pressure at Discharge
Measured: Up to 96 hours postpartum
Aims 2-5: Diastolic Blood Pressure at Discharge
Measured: Up to 96 hours postpartum
Aims 2-5: Medication at Discharge
Measured: up to 96 hours postpartum
Aims 2-5: Postpartum Day of Discharge
Measured: up to 4.5 days
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Measured: up to 4 days post-partum
Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery
Measured: 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.
Measured: 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.
Measured: up to 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 201711 Jun 2018

First posted12 Apr 2017
Study start23 Mar 2017
Primary completion8 Jun 2018
Study completion11 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03111095
Sponsor's protocol ID: 2017-003
Status last verified: Jul 2024
First submitted: 24 Mar 2017
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 32439388
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.
PubMed 33607957
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.
PubMed 30825917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia

All Hypertension, Pregnancy-Induced trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension
ClinicalTrials.gov ID: NCT03111095
Acronym / sponsor ID: 2017-003
Conditions: Hypertension, Pregnancy-Induced
Study type: Interventional
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 23 Mar 2017 (actual)
Primary completion: 8 Jun 2018 (actual)
Study completion: 11 Jun 2018 (actual)
First posted: 12 Apr 2017 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mobile Health Participants	Experimental	Other: Mobile HealthSubjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
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.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (1 listed)

Inability to obtain informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile HealthSubjects 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.	Other	Mobile Health Participants

Primary outcome

Aim 1: Number of Participants Enrolled
Time frame: up to 3 months
A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.
Aim 1: Number of Participants Who Completed the Study
Time frame: up to 6 weeks
To assess retention, the number of participants who completed the study will be reported.
Aims 2-5: Number of Participants Enrolled in 1 Year
Time frame: up to 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).
Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions
Time frame: up to 6 weeks postpartum
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).

17 secondary outcomes

Aim 1: 6-week Hospital Readmission
Time frame: up to 6 weeks
Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge
Time frame: up to 6 weeks
Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits
Time frame: up to 6 weeks postpartum
Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge
Time frame: up to 6 weeks
Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits
Time frame: up to 6 weeks postpartum
Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery
Time frame: up to 10 days of delivery
Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes
Time frame: up to 6 weeks postpartum
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
Time frame: Admission to delivery (up to 96 hours)
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
Time frame: Admission to delivery (up to 96 hours)
Aims 2-5: Systolic Blood Pressure at Discharge
Time frame: Up to 96 hours postpartum
Aims 2-5: Diastolic Blood Pressure at Discharge
Time frame: Up to 96 hours postpartum
Aims 2-5: Medication at Discharge
Time frame: up to 96 hours postpartum
Aims 2-5: Postpartum Day of Discharge
Time frame: up to 4.5 days
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Time frame: up to 4 days post-partum
Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery
Time frame: 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
Time frame: up to 6 weeks postpartum
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Time frame: up to 6 weeks postpartum

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Health Participants	55	52
Standard of Care	0	0

Primary outcome: Aim 1: Number of Participants Enrolled

Time frame: up to 3 months. Count of participants. Unit: Participants

Measure	Mobile Health Participants n = 55
Value	55

Population analysed: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

Primary outcome: Aim 1: Number of Participants Who Completed the Study

Time frame: up to 6 weeks. Count of participants. Unit: Participants

Measure	Mobile Health Participants n = 55
Value	52

Population analysed: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

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

Time frame: up to 1 year. Count of participants. Unit: Participants

Measure	Mobile Health Participants n = 214	Standard of Care n = 214
Value	214	214

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

Time frame: up to 6 weeks postpartum. Count of participants. Unit: Participants

Measure	Mobile Health Participants n = 214	Standard of Care n = 214
Value	1	8

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 6 weeks post partum. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Health Participants	0 of 214 (0%)	0 of 214 (0%)	0 of 214
Standard of Care	0 of 214 (0%)	0 of 214 (0%)	0 of 214

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32439388Hoppe 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.
Results publication: PubMed 33607957Thomas 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.
Results publication: PubMed 30825917Hoppe 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.
Individual participant dataSharing planned: No

Related trials for Hypertension, Pregnancy-Induced

RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kara Hoppe, DO principal investigator

Clinical Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Health in people with Hypertension, Pregnancy-Induced, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aim 1: Number of Participants Enrolled (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03111095, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.