Hypertensive Disorder of PregnancyPhase 4NCT06069102
Optimal Blood Pressure Treatment Thresholds Postpartum
A Phase 4 study of Hypertensive Disorder of Pregnancy and Pre-Eclampsia, run by Alisse Hauspurg at 1 site in United States.
Trial summary
The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 1 Dec 2025
- Phase
- Phase 4
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum individuals ≥18 years old
- Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
- Enrolled in remote BP management program.
Who cannot join
- Pre-pregnancy hypertension
- Pre-pregnancy diabetes
- Maternal cardiac disease
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial
The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP).
The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
Read the detailed description
The investigators will determine the feasibility of conducting a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home BP monitoring) vs. standard of care (<150/100 mmHg on home BP monitoring) in postpartum individuals following a HDP with assessment of individuals who are eligible, enrolled, and remain in the study until six weeks postpartum. Individuals who are retained in the study for 6 months postpartum. Lastly, investigators will analyze effect outcomes to inform the sample size for a subsequent large-scale randomized trial. This will be done through analysis of mean arterial pressure (MAP), systolic blood pressure, and diastolic blood pressure of participants at 6 weeks and at 6 months postpartum. The study will be conducted on the postpartum unit of Magee-Womens Hospital. Participants will be enrolled at the time of postpartum hospitalization with study visit #1 occurring in the hospital. At this study visit, participants will be administered questionnaires, will provide a blood sample, and BP will be measured. Study visit #2 will be a remote study visit conducted via telemedicine or a telephone call at 6 weeks postpartum. At this visit, participants will provide questionnaires and blood pressure data. Study visit #3 will be a remote study visit conducted via telemedicine or a telephone call at 6 months postpartum. At this visit, participants will again provide questionnaires and blood pressure data.
- Conditions
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension, Eclampsia, Gestational Hypertension, Cardiovascular Diseases
- Being tested
- Usual care, Tight blood pressure control
- Keywords
- Hypertension
- Medical subject headings
- Toxemia, Pre-Eclampsia, Hypertension, Eclampsia, Hypertension, Pregnancy-Induced, Cardiovascular Diseases, Pregnancy Complications, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careDrug
The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
Tight blood pressure controlDrug
Also called Tight control
The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. Receives: Drug: Usual care |
| Intervention (Tight Blood Pressure Control) Group | Experimental | BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. Receives: Drug: Tight blood pressure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants Eligible, Enrolled and Retained (Feasibility)
To determine if a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home blood pressure monitoring) vs. standard of care (<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.
Measured: Baseline to approximately 6 months postpartum, a total of 6 months postpartum
Secondary outcomes (12)
Number of Participants With Anti-hypertensive Medication Use
Number of participants with anti-hypertensive medication use
Measured: 6 months postpartum
Anti-hypertensive Medication Use
Anti-hypertensive medication use
Measured: 6 weeks postpartum
Mean Arterial Pressure (Efficacy)
Mean arterial pressure (systolic BP + 2*diastolic BP / 3)
Measured: 6 months postpartum
Mean Arterial Pressure
Mean arterial pressure (systolic BP + 2*diastolic BP / 3)
Measured: 6 weeks postpartum
Systolic Blood Pressure
Mean systolic blood pressure
Measured: 6 months postpartum
Diastolic Blood Pressure
Mean diastolic blood pressure
Measured: 6 months postpartum
Diastolic Blood Pressure
Mean diastolic blood pressure
Measured: 6 weeks postpartum
Change in MAP
Change in mean arterial pressure (systolic BP + 2*diastolic BP / 3) from baseline
Measured: 6 weeks postpartum
Change in Systolic BP
Change in systolic BP from baseline
Measured: 6 weeks postpartum
Change in Diastolic BP
Change in diastolic BP from baseline
Measured: 6 weeks postpartum
Number of Participants With Hospital Readmissions
Postpartum hospital readmissions
Measured: Six months postpartum
Number of Participants With ER Visits
Emergency room visits
Measured: Six months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start15 Nov 2023
- Primary completion1 May 2025
- Study completion1 Dec 2025
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.
- Other trials for Hypertensive Disorder of PregnancyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alisse Hauspurg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alisse Hauspurg, University of Pittsburgh
- Investigators
- Alisse K Hauspurg, MD, Principal investigator, UPMC Magee Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069102
- Sponsor's protocol ID
- STUDY23060147
- Status last verified
- May 2026
- First submitted
- 28 Sep 2023
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data (including data dictionaries) will be shared at the direction of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available. The dataset for our project will be prepared according to requirements for and stored on the Clinicaltrials.gov data repository. Per the NIH guidelines, the dataset will be submitted to the program officer within a year after the outcomes are published and no later than 3 years after the end of clinical activities.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial
- ClinicalTrials.gov ID
- NCT06069102
- Acronym / sponsor ID
- STUDY23060147
- Conditions
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension, Eclampsia, Gestational Hypertension, Cardiovascular Diseases
- Keywords
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Alisse HauspurgUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP).
The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
Detailed description
The investigators will determine the feasibility of conducting a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home BP monitoring) vs. standard of care (<150/100 mmHg on home BP monitoring) in postpartum individuals following a HDP with assessment of individuals who are eligible, enrolled, and remain in the study until six weeks postpartum. Individuals who are retained in the study for 6 months postpartum. Lastly, investigators will analyze effect outcomes to inform the sample size for a subsequent large-scale randomized trial. This will be done through analysis of mean arterial pressure (MAP), systolic blood pressure, and diastolic blood pressure of participants at 6 weeks and at 6 months postpartum. The study will be conducted on the postpartum unit of Magee-Womens Hospital. Participants will be enrolled at the time of postpartum hospitalization with study visit #1 occurring in the hospital. At this study visit, participants will be administered questionnaires, will provide a blood sample, and BP will be measured. Study visit #2 will be a remote study visit conducted via telemedicine or a telephone call at 6 weeks postpartum. At this visit, participants will provide questionnaires and blood pressure data. Study visit #3 will be a remote study visit conducted via telemedicine or a telephone call at 6 months postpartum. At this visit, participants will again provide questionnaires and blood pressure data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Drug: Usual careStandard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. |
| Intervention (Tight Blood Pressure Control) Group | Experimental | Drug: Tight blood pressure controlBP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postpartum individuals ≥18 years old
- Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
- Enrolled in remote BP management program.
Key exclusion criteria (4 listed)
- Pre-pregnancy hypertension
- Pre-pregnancy diabetes
- Maternal cardiac disease
- Chronic kidney disease
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 |
|---|---|---|
| Usual careThe usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently. | Drug | Usual Care Group |
| Tight blood pressure controlAlso: Tight controlThe intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg. | Drug | Intervention (Tight Blood Pressure Control) Group |
Primary outcome
Percent of Participants Eligible, Enrolled and Retained (Feasibility)
Time frame: Baseline to approximately 6 months postpartum, a total of 6 months postpartum
To determine if a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home blood pressure monitoring) vs. standard of care (<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.
12 secondary outcomes
Number of Participants With Anti-hypertensive Medication Use
Time frame: 6 months postpartum
Anti-hypertensive Medication Use
Time frame: 6 weeks postpartum
Mean Arterial Pressure (Efficacy)
Time frame: 6 months postpartum
Mean Arterial Pressure
Time frame: 6 weeks postpartum
Systolic Blood Pressure
Time frame: 6 months postpartum
Diastolic Blood Pressure
Time frame: 6 months postpartum
Diastolic Blood Pressure
Time frame: 6 weeks postpartum
Change in MAP
Time frame: 6 weeks postpartum
Change in Systolic BP
Time frame: 6 weeks postpartum
Change in Diastolic BP
Time frame: 6 weeks postpartum
Number of Participants With Hospital Readmissions
Time frame: Six months postpartum
Number of Participants With ER Visits
Time frame: Six months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data (including data dictionaries) will be shared at the direction of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available. The dataset for our project will be prepared according to requirements for and stored on the Clinicaltrials.gov data repository. Per the NIH guidelines, the dataset will be submitted to the program officer within a year after the outcomes are published and no later than 3 years after the end of clinical activities.
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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.
Alisse K Hauspurg, MD principal investigator
UPMC Magee Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Hypertensive Disorder of Pregnancy and Pre-Eclampsia, run by Alisse Hauspurg 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 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: finished, as of the sponsor's last update on 2 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2026). 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?
Percent of Participants Eligible, Enrolled and Retained (Feasibility) (time frame: Baseline to approximately 6 months postpartum, a total of 6 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 2 Jun 2026.