Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

NCT05849103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2026-03-12

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849103 on ClinicalTrials.gov