PostpartumNCT07204756
HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring
A study testing 2-Week Home Monitoring and 6-Week Home Monitoring in people with Postpartum and Hypertension, run by University of Minnesota at 1 site in United States.
Trial summary
Postpartum remote blood pressure monitoring programs for patients with hypertensive disorders of pregnancy (HDP) are becoming part of standard postpartum management. Existing programs range in duration from 2 to 6 weeks but there has not been any evaluation as to what program duration is optimal. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum, Hypertension, Hypertensive Disorder of Pregnancy
- What is being tested?
- 2-Week Home Monitoring and 6-Week Home Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Discharged after delivery at University of Minnesota Medical Center
- Enrolled into the HOPE-BP Program
Who cannot join
- Ongoing antihypertensive medication use at 2 weeks (time of randomization)
- Have a medical comorbidity that would not be clinically appropriate to randomize
- Patients opted out of clinical research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Erin Linden, 612-625-2273, linde491@umn.edu
About this study
Postpartum remote blood pressure monitoring programs for patients with hypertensive disorders of pregnancy (HDP) are becoming part of standard postpartum management. Existing programs range in duration from 2 to 6 weeks but there has not been any evaluation as to what program duration is optimal. The primary objective of this study is to evaluate the impact of program duration on clinical outcomes for patients participating in a single institution's postpartum remote blood pressure monitoring program for patients with HDP.
- Conditions
- Postpartum, Hypertension, Hypertensive Disorder of Pregnancy
- Being tested
- 2-Week Home Monitoring, 6-Week Home Monitoring
- Medical subject headings
- Hypertension, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Week Home MonitoringDiagnostic test
Those who are randomized into the 2-week intervention arm will be unenrolled from the postpartum remote blood pressure monitoring program and therefore will no longer be transmitting twice daily blood pressures for review.
6-Week Home MonitoringDiagnostic test
HOPE-BP provides remote monitoring for the 35% of approximately 2,800 annual births at our institution complicated by HDP. Eligible patients enroll at hospital discharge into a 6-week program, submitting blood pressure readings twice daily via Epic's MyChart Care Companion. Participants receive immediate automated feedback, and a dedicated Maternal Fetal Medicine nursing team reviews data daily (Monday-Friday, 8 AM-4 PM), initiating or adjusting antihypertensive therapy as needed.
| Study group | Role | What they receive |
|---|---|---|
| 2-Week Arm | Active comparator | Participants randomized into the 2 week arm will be immediately unenrolled from the postpartum remote blood pressure monitoring program and resume standard postpartum care Receives: Diagnostic Test: 2-Week Home Monitoring |
| 6-Week Arm | Active comparator | Patients randomized into the 6 week arm will continue and complete the program in its entirety per current SOC (4 additional weeks) Receives: Diagnostic Test: 6-Week Home Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic Blood Pressure
The primary outcome will be the patient's diastolic blood pressure (DBP) at their 6-week postpartum visit.
Measured: Week 6
Secondary outcomes (6)
Systolic Blood Pressure at 6 weeks post-partum
Patient's systolic blood pressure at their 6-week postpartum visit
Measured: Week 6
6-Week Post-partum Follow-up Rates
Participants who complete a 6-week post-partum visit / Total participants eligible for a 6-week post-partum visit
Measured: Week 6
Unscheduled OB visit, triage visit, ED visit, or readmission rates
Measured: Week 6
Patient Satisfaction Survey responses at 6 weeks
PSS Score, where higher score indicates greater satisfaction
Measured: Week 6
Rate of severe hypertension
defined as systolic blood pressure ≥ 160mmHg and/or DBP ≥ 110 mmHg
Measured: Week 6
Rate of new hypertension diagnosis at 6 weeks postpartum
based on American Heart Association and American College of Cardiology criteria (AHA/ACC)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start7 Jan 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bethany Sabol, MD MAS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204756
- Sponsor's protocol ID
- OBGYN-2025-34107
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT07204756
- Acronym / sponsor ID
- OBGYN-2025-34107
- Conditions
- Postpartum, Hypertension, Hypertensive Disorder of Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum remote blood pressure monitoring programs for patients with hypertensive disorders of pregnancy (HDP) are becoming part of standard postpartum management. Existing programs range in duration from 2 to 6 weeks but there has not been any evaluation as to what program duration is optimal. The primary objective of this study is to evaluate the impact of program duration on clinical outcomes for patients participating in a single institution's postpartum remote blood pressure monitoring program for patients with HDP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-Week Arm | Active comparator | Diagnostic Test: 2-Week Home MonitoringParticipants randomized into the 2 week arm will be immediately unenrolled from the postpartum remote blood pressure monitoring program and resume standard postpartum care |
| 6-Week Arm | Active comparator | Diagnostic Test: 6-Week Home MonitoringPatients randomized into the 6 week arm will continue and complete the program in its entirety per current SOC (4 additional weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Discharged after delivery at University of Minnesota Medical Center
- Enrolled into the HOPE-BP Program
Key exclusion criteria (3 listed)
- Ongoing antihypertensive medication use at 2 weeks (time of randomization)
- Have a medical comorbidity that would not be clinically appropriate to randomize
- Patients opted out of clinical research
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 |
|---|---|---|
| 2-Week Home MonitoringThose who are randomized into the 2-week intervention arm will be unenrolled from the postpartum remote blood pressure monitoring program and therefore will no longer be transmitting twice daily blood pressures for review. | Diagnostic test | 2-Week Arm |
| 6-Week Home MonitoringHOPE-BP provides remote monitoring for the 35% of approximately 2,800 annual births at our institution complicated by HDP. Eligible patients enroll at hospital discharge into a 6-week program, submitting blood pressure readings twice daily via Epic's MyChart Care Companion. Participants receive immediate automated feedback, and a dedicated Maternal Fetal Medicine nursing team reviews data daily (Monday-Friday, 8 AM-4 PM), initiating or adjusting antihypertensive therapy as needed. | Diagnostic test | 6-Week Arm |
Primary outcome
Diastolic Blood Pressure
Time frame: Week 6
The primary outcome will be the patient's diastolic blood pressure (DBP) at their 6-week postpartum visit.
6 secondary outcomes
Systolic Blood Pressure at 6 weeks post-partum
Time frame: Week 6
6-Week Post-partum Follow-up Rates
Time frame: Week 6
Unscheduled OB visit, triage visit, ED visit, or readmission rates
Time frame: Week 6
Patient Satisfaction Survey responses at 6 weeks
Time frame: Week 6
Rate of severe hypertension
Time frame: Week 6
Rate of new hypertension diagnosis at 6 weeks postpartum
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Bethany Sabol, MD MAS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-Week Home Monitoring and 6-Week Home Monitoring in people with Postpartum and Hypertension, run by University of Minnesota 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Linden (612-625-2273, linde491@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic Blood Pressure (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.