Hypertension, Pregnancy InducedSMART BPNCT07209254
Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
A study testing High-touch blood pressure management and Low-touch blood pressure management in people with Hypertension, Pregnancy Induced, run by Jennifer Lewey, MD, MPH at 3 sites in United States.
Trial summary
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension, Pregnancy Induced
- What is being tested?
- High-touch blood pressure management and Low-touch blood pressure management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Mar 2026to Nov 2029
- 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
- Age ≥18 years
- Delivery within 14 days
- Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum
- Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum
- English or Spanish speaking (able to read/understand consent and instructions)
- Has phone texting capabilities
Who cannot join
- Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia)
- Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery)
- Chronic kidney disease (stage 3 or higher)
- Using ≥3 BP medications at time of enrollment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexis Giron, M.S contact
United States3 sites, 3 recruiting
- Not yet recruiting
The Ohio State University
Columbus, Ohio, 43210
Anna Bartholomew, MPH, BSN, RN, 614-685-3229, anna.bartholomew@osumc.edu
Maged Costantine, MD
- Recruiting
NYU Langone Health
New York, New York, 10022
Christina Penfield, MD, MPH, (646)-754-2700, christina.penfield@nyulangone.org
Michelle Rojas, (646) 679-0737, smart-bp@nyulangone.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alexis Giron, M.S, 215-275-2507, Alexis.Giron@Pennmedicine.upenn.edu
Meaghan McCabe, MPH
About this study
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health
- Conditions
- Hypertension, Pregnancy Induced
- Being tested
- High-touch blood pressure management, Low-touch blood pressure management
- Keywords
- Postpartum Hypertension, Blood pressure management, Preeclampsia, Hypertension, pregnancy induced
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-touch blood pressure managementOther
Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care
Low-touch blood pressure managementOther
10 days of text-based home blood pressure monitoring
| Study group | Role | What they receive |
|---|---|---|
| High-touch blood pressure management | Experimental | Not described Receives: Other: High-touch blood pressure management |
| Low-touch blood pressure management | Experimental | Not described Receives: Other: Low-touch blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diastolic blood pressure (DBP)
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
Measured: 12 months postpartum
Secondary outcomes (10)
Blood pressure outcome: Mean systolic blood pressure (SBP)
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
Measured: 12 months postpartum
Blood pressure outcome: Mean nocturnal DBP
Assessed by ABPM
Measured: 12 months postpartum
Blood pressure outcome: Mean nocturnal SBP
Assessed by ABPM
Measured: 12 months postpartum
Blood pressure outcome: Mean DBP
Assessed by home blood pressure monitor and office measurement
Measured: 12 months postpartum
Chronic Hypertension
Defined as 24-hour mean systolic blood pressure greater than or equal to 12mmHg, mean diastolic blood pressure greater than or equal to 75mmHg as assessed by ABPM or taking BP medication
Measured: 12 months postpartum
Echocardiogram Outcomes
Patients will all undergo a routine transthoracic echocardiogram. Measurements include: Left ventricle (LV) mass index, Relative wall thickness, mean E/e' ratio, left atrial (LA) volume index, global longitudinal strain.
Measured: 12 months postpartum
Patient Reported Outcome - Patient Activation Measure
Patient Activation Measure (PAM) is a 10 survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. Scored on a scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.
Survey will be completed at 3 timepoints: at randomization, 6-10 weeks postpartum, and 12 months postpartum
Measured: Post-randomization to 1 year postpartum
Patient Reported Outcome - Perceived Stress
Scores from the validated Perceived Stress Scale (PSS-10) will be calculated using standard scoring criteria for each of the 10 items. Higher scores are correlated with more perceived stress.
Survey to be completed at randomization, at 6-10 weeks postpartum, and at 1 year postpartum.
Measured: Post-randomization to 1 year postpartum
Patient Reported Outcome - Self-Efficacy
New General Self-Efficacy Scale is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties. Using a 5-point rating scale where 1=strongly disagree and 5=strongly agree, scores are calculated by taking the average of their ratings. Survey to be completed at randomization, at 6-10 weeks postpartum, and at 1 year postpartum.
Measured: Post randomization to 1 year postpartum
Implementation Outcome: Acceptability of Intervention
Patients will be asked questions to assess the acceptability of the intervention. The questions will be scored on a Likert response scales from 1 to 5. Higher scores represent higher acceptability. Asked at two time points, 6 weeks and 12 months postpartum.
Measured: From 6 weeks postpartum through 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start2 Mar 2026
- Primary completionOct 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Pregnancy InducedStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Lewey, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Jennifer Lewey, MD, MPH, University of Pennsylvania
- Investigators
- Jennifer Lewey, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209254
- Sponsor's protocol ID
- 858860
- Acronym
- SMART BP
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
- ClinicalTrials.gov ID
- NCT07209254
- Acronym / sponsor ID
- SMART BP / 858860
- Conditions
- Hypertension, Pregnancy Induced
- Keywords
- Postpartum Hypertension, Blood pressure management, Preeclampsia, Hypertension, pregnancy induced
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Jennifer Lewey, MD, MPHUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 6 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.
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-touch blood pressure management | Experimental | Other: High-touch blood pressure management |
| Low-touch blood pressure management | Experimental | Other: Low-touch blood pressure management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Delivery within 14 days
- Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum
- Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum
- English or Spanish speaking (able to read/understand consent and instructions)
Key exclusion criteria (4 listed)
- Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia)
- Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery)
- Chronic kidney disease (stage 3 or higher)
- Using ≥3 BP medications at time of enrollment
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 |
|---|---|---|
| High-touch blood pressure managementTwelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care | Other | High-touch blood pressure management |
| Low-touch blood pressure management10 days of text-based home blood pressure monitoring | Other | Low-touch blood pressure management |
Primary outcome
Mean diastolic blood pressure (DBP)
Time frame: 12 months postpartum
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
10 secondary outcomes
Blood pressure outcome: Mean systolic blood pressure (SBP)
Time frame: 12 months postpartum
Blood pressure outcome: Mean nocturnal DBP
Time frame: 12 months postpartum
Blood pressure outcome: Mean nocturnal SBP
Time frame: 12 months postpartum
Blood pressure outcome: Mean DBP
Time frame: 12 months postpartum
Chronic Hypertension
Time frame: 12 months postpartum
Echocardiogram Outcomes
Time frame: 12 months postpartum
Patient Reported Outcome - Patient Activation Measure
Time frame: Post-randomization to 1 year postpartum
Patient Reported Outcome - Perceived Stress
Time frame: Post-randomization to 1 year postpartum
Patient Reported Outcome - Self-Efficacy
Time frame: Post randomization to 1 year postpartum
Implementation Outcome: Acceptability of Intervention
Time frame: From 6 weeks postpartum through 1 year postpartum
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 22 May 2026.
- Individual participant dataSharing planned: Yes
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
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
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.
Alexis Giron, M.S contact
Jennifer Lewey, MD, MPH principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-touch blood pressure management and Low-touch blood pressure management in people with Hypertension, Pregnancy Induced, run by Jennifer Lewey, MD, MPH at 3 sites 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 6 inclusion and 4 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Jennifer Lewey, MD, MPH (215-662-7700, Jennifer.Lewey@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean diastolic blood pressure (DBP) (time frame: 12 months postpartum). 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 22 May 2026.