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N/A N=343 Randomized Single-blind Health Services Research

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

Hypertension, Pregnancy-Induced · Postpartum Preeclampsia · Hypertension; Maternal

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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