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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05849103
Other study ID # R21NR020857-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date April 1, 2028

Study information

Verified date June 2024
Source Vanderbilt University Medical Center
Contact Sarah Osmundson, MD
Phone 615-343-5700
Email sarah.osmundson@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Blood Pressure Control Targets
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
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.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (7)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Alex Phelps, MD, Etoi Garrison, MD, PhD, Julia Phillippi, PhD, CNM, Kathryn Lindley, MD, Sarah Osmundson, MD, MS, Soha Patel, MD, MSPH

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction with postpartum care Scale of 1-10 6 weeks post delivery
Other Satisfaction with blood pressure care Scale of 1-10 6 weeks post delivery
Other Proportion of patients who respond 'yes' to feeling that their voice is heard Feeling that their voice is heard 2 weeks post delivery
Other Perceived Stress (NIH Toolbox) mean T-score (Range 1-100) 2 weeks post delivery
Other Self-Efficacy (PROMIS measure) mean T-score (Range 1-100) 2 weeks post delivery
Other Edinburgh Postpartum Depression Scale Mean score (range 1-30) 2 weeks post delivery
Other Mothers on Respect Index Score mean score (range 14-84) 6 weeks post delivery
Primary Proportion of participants with recorded blood pressure values in office Proportion of participants with blood pressure values recorded in the office 7-10 days post delivery
Secondary Proportion of participants with recorded blood pressure values, any reporting Proportion of participants with blood pressure values recorded through any means 7-10 days post delivery
Secondary Mean systolic blood pressure, 7-10 days Mean systolic blood pressure 7-10 days post delivery
Secondary Mean diastolic blood pressure, 7-10 days Mean diastolic blood pressure 7-10 days post delivery
Secondary Mean systolic blood pressure, 4-6 weeks post delivery Mean systolic blood pressure 4-6 weeks post delivery
Secondary Mean diastolic blood pressure, 4-6 weeks post delivery Mean diastolic blood pressure 4-6 weeks post delivery
Secondary Proportion of patients who initiated or increased medications Initiated or increased medications 6 weeks post delivery
Secondary Number of contacts with the health care team Number of contacts with the health care team 6 weeks post delivery
Secondary Proportion of patients with sustained severe hypertension Two blood pressures >=160/100 at least 15 minutes apart 6 weeks post delivery
Secondary Proportion of patients with obstetric triage or emergency department visit Obstetric triage or emergency department visit 6 weeks post delivery
Secondary Proportion of patients with hospital readmission for hypertension Hospital readmission for hypertension 6 weeks post delivery
Secondary Proportion of patients with postpartum visit attendance Postpartum visit attendance 3-6 weeks post delivery
Secondary Proportion of patients with primary care visit attendance Primary care visit attendance 3 months post delivery
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