RECRUITING

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

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

This is a single site, single-blinded parallel randomized control trial that investigates a multi-level intervention to improve postpartum blood pressure in women with hypertensive disorder pregnancy. The investigators will recruit women diagnosed with a hypertensive disorder of pregnancy, identified between 3rd trimester and 2 weeks post-delivery. The investigators will randomize participants to receive usual care home blood pressure monitoring for 6 weeks versus an intervention of usual care + blood pressure and weight monitoring + a doula trained in heart health. This trial will be conducted in partnership with a local community-based organization, Healthy Start Inc.

Official Title

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

Quick Facts

Study Start:2023-06-29
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05655936

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

Study Contact

Janet Catov, PhD
CONTACT
412-641-6217
catovjm@mwri.magee.edu
Esa Davis, MD
CONTACT
410-706-4116
Esa.Davis@som.umaryland.edu

Principal Investigator

Janet Catov, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Janet Catov, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2023-06-29
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2023-06-29
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Postpartum Doula, Doula Intervention

Additional Relevant MeSH Terms

  • Preeclampsia
  • Hypertensive Disorder of Pregnancy
  • Toxemia
  • Pregnancy Complications
  • Hypertension, Pregnancy-Induced
  • Hypertension
  • Obesity
  • Overweight
  • Nutrition Disorders
  • Vascular Diseases
  • Cardiovascular Diseases
  • Pre-Eclampsia
  • Eclampsia
  • Gestational Hypertension