Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
NCT05849103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343
Last updated 2026-03-12
Summary
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
Conditions
- Hypertension, Pregnancy-Induced
- Postpartum Preeclampsia
- Hypertension; Maternal
Interventions
- OTHER
-
Blood Pressure Control Targets
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
- OTHER
-
Hypertension Management
This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.
Sponsors & Collaborators
-
Sarah Osmundson, MD, MS
collaborator UNKNOWN -
Alex Phelps, MD
collaborator UNKNOWN -
Julia Phillippi, PhD, CNM
collaborator UNKNOWN -
Soha Patel, MD, MSPH
collaborator UNKNOWN -
Etoi Garrison, MD, PhD
collaborator UNKNOWN -
Kathryn Lindley, MD
collaborator UNKNOWN -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Sarah Osmundson, MD · Associate Professor Maternal-Fetal Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-08
- Primary Completion
- 2024-08-01
- Completion
- 2024-08-01
Countries
- United States
Study Locations
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