N/A
N=343
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Hypertension, Pregnancy-Induced · Postpartum Preeclampsia · Hypertension; Maternal
Bottom Line
View on ClinicalTrials.gov: NCT05849103 ↗Enrolled (actual)
343
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Proportion of Participants With Recorded Blood Pressure Values in Office — 43; 44; 49; 56 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Pressure Control Targets (Other); Hypertension Management (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Recorded Blood Pressure Values in Office |
43; 44; 49; 56 | — |
| SECONDARY Proportion of Participants With Recorded Blood Pressure Values, Any Reporting |
48; 47; 76; 78 | — |
| SECONDARY Systolic Blood Pressure, 7-10 Days |
130; 132; 128; 128 | — |
| SECONDARY Diastolic Blood Pressure |
84; 82; 84; 84 | — |
| SECONDARY Systolic Blood Pressure, 4-6 Weeks |
125.1; 124.1; 121.1; 124.2 | — |
| SECONDARY Diastolic Blood Pressure, 4-6 Weeks |
78.2; 79.9; 78.6; 78.7 | — |
| SECONDARY Initiated New Medications |
9; 7; 4; 17 | — |
| SECONDARY Sustained Severe Hypertension, 7-10 Days |
6; 5; 6; 9 | — |
| SECONDARY Unplanned Visits |
13; 10; 10; 12 | — |
| SECONDARY Postpartum Visit Attendance |
66; 66; 67; 71 | — |
| SECONDARY Primary Care Visit Attendance |
29; 20; 44; 48 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >18 years
- Diagnosed with a Hypertensive Disorder of Pregnancy (HDP), which includes chronic hypertension, preeclampsia, gestational hypertension, HELLP Syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets), or eclampsia (O10, O11, O13, O14, O15, O16) Exclusion Criteria
- Not able or willing to receive electronic surveys 2. Deemed inappropriate for study enrollment by the bedside nurse 3. Non-English speaking 4. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)
Data sourced from ClinicalTrials.gov (NCT05849103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.