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Optimal BP Treatment Thresholds for Postpartum High Blood Pressure
Phase 4
Recruiting
Led By Alisse K Hauspurg, MD
Research Sponsored by Alisse Hauspurg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Postpartum individuals ≥18 years old
* Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months postpartum
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will assess whether tight BP control in postpartum people with HDP can reduce BP & hospital readmissions. Up to 60 people will be studied at Magee-Women's Hospital.
Who is the study for?
This trial is for postpartum individuals over 18 who were diagnosed with preeclampsia or gestational hypertension. Participants must be enrolled in a remote blood pressure management program.
What is being tested?
The study is testing whether tight control of blood pressure after giving birth (using specific medication thresholds) leads to better outcomes than usual care, including lower BP at six months and fewer hospital readmissions.
What are the potential side effects?
Potential side effects are not explicitly listed, but may include those commonly associated with blood pressure medications such as dizziness, headache, fatigue, or changes in kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of participants eligible, enrolled and retained (feasibility)
Secondary study objectives
Anti-hypertensive medication use
Anti-hypertensive medication use (efficacy)
Change in MAP
+8 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (Tight Blood Pressure Control) GroupExperimental Treatment1 Intervention
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.
Group II: Usual Care GroupActive Control1 Intervention
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
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Who is running the clinical trial?
Alisse HauspurgLead Sponsor
2 Previous Clinical Trials
170 Total Patients Enrolled
Alisse K Hauspurg, MDPrincipal InvestigatorUPMC Magee Women's Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled