Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05884190

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

Led by Yale University · Updated on 2025-04-09

6030

Participants Needed

3

Research Sites

224 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Delivered a single live baby (twins reduced to singleton or vanishing twin syndrome before 14 weeks qualify)
  • Currently postpartum
  • Speak English or Spanish
  • Pregnancy reached at least 24 weeks of gestation (child may be in NICU)
  • Have Medicaid, equivalent insurance, or are uninsured
  • Live in Connecticut, Massachusetts, or New York, preferably near study hospitals
Not Eligible

You will not qualify if you...

  • Multiple pregnancy (twins or more)
  • Pregnancy less than 24 weeks gestation
  • Known major fetal anomaly or stillbirth
  • Currently using illicit drugs (e.g., cocaine, heroin, fentanyl) as noted at delivery
  • Active suicidal thoughts with intent and plan
  • Diagnosed primary psychotic disorder (e.g., schizophrenia)
  • Planning to move out of state within 6 months
  • Unable to give consent
  • Severe medical issues preventing study participation (e.g., active cancer treatment, dialysis)
  • Provider or patient refusal
  • Incarcerated or institutionalized
  • Stillbirth
  • Newborn under care of others (e.g., adoption) will be evaluated individually for eligibility
  • No phone or device access for telehealth communication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06520

Actively Recruiting

2

University of Massachusetts Memorial Health

Worcester, Massachusetts, United States, 01655

Actively Recruiting

3

Oishei Children's Hospital University at Buffalo

Buffalo, New York, United States, 14203

Actively Recruiting

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Research Team

R

Rafael Pérez-Escamilla, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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