COMPLETED

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled

Quick Facts

Study Start:2023-05-08
Study Completion:2024-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05849103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Sarah Osmundson, MD
PRINCIPAL_INVESTIGATOR
Associate Professor Maternal-Fetal Medicine

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37215
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Sarah Osmundson, MD, PRINCIPAL_INVESTIGATOR, Associate Professor Maternal-Fetal Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08
Study Completion Date2024-08-01

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2024-08-01

Terms related to this study

Keywords Provided by Researchers

  • Hypertension
  • Postpartum hypertension

Additional Relevant MeSH Terms

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