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Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension

NCT05884190 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6030

Last updated 2025-04-09

No results posted yet for this study

Summary

The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications. The investigators will accomplish this by comparing the effectiveness of two multi-component multi-level healthcare delivery models focused on early detection and control of postpartum hypertension and the social and mental health factors known to impact maternal outcomes, with the current standard of care and with each other.

Conditions

  • Postpartum Hypertension

Interventions

OTHER

Remote Medical Model (RMM)

Remote home blood pressure (BP) monitoring once a day for the first 7 days and then at least weekly or more frequently as per a standardized blood pressure protocol up to six weeks and weekly virtual visits for 6 weeks and up to 12 weeks as needed by a physician extender (e.g. Nurse Practitioner, Pharmacist, etc.), and screening for social determinants of health and anxiety/ depression with referral for services if positive

OTHER

Community Health Model (CHM)

Utilization of community health workers trained in a strength-based trauma informed dyadic evidence-based approach.

OTHER

SoC

SoC for Postpartum Hypertension

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Rafael Pérez-Escamilla, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2027-10-31
Completion
2027-10-31

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 NCT05884190 on ClinicalTrials.gov