Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
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
🗓️ Study Start (Actual) 12 June 2023
🗓️ Primary Completion (Estimated) October 2027
✅ Study Completion (Estimated) October 2027
👥 Enrollment (Estimated) 6030
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New Haven, Connecticut, United States
📍 Worcester, Massachusetts, United States
📍 Buffalo, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Delivery of singleton live birth (twins reduced to singleton or with vanishing twin syndrome prior to 14 weeks qualify)
    • * Postpartum
    • * English or Spanish speaking
    • * Viable pregnancy 24 weeks of gestation or above (Child can be in NICU to participate)
    • * Medicaid or the equivalent within each state (for example, Connecticut has Husky insurance) or uninsured
    • * Must living in one of the three states involved in this study (Connecticut, Massachusetts, New York) and preferably within the geographical area of each of the hospitals

    Exclusion Criteria:

    • * Multifetal pregnancy (since are they at increased risk for key outcomes)
    • * Gestational age \<24 weeks;
    • * Known major fetal anomaly in current pregnancy or stillbirth
    • * Actively using illicit/illegal substances (such as cocaine, heroin and other types of illicit opiates such as fentanyl) as noted in delivery hospitalization notes
    • * Active suicidal ideation with intent and plan
    • * Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder)
    • * Plans to move out of the state within 6 months
    • * Incapable of consent
    • * Severe medical complications that don't allow a mother to do the study effectively (for example, active treatment for cancer, dialysis etc. )
    • * Physician or provider refusal
    • * Patient refusal
    • * Incarcerated or institutionalized
    • * Stillbirth
    • Births that result in the newborn being under the care of another person or institution other than the birthing individual (e.g. adoption, state involvement) will be evaluated on an individual basis to determine if that person should be included.
    • For participants without access to a phone, we will explore if there are options that will allow them to have access to a devise for the times when they need to communicate with the study team. If not, they will not be able to participate in the study since this study requires phone or telehealth communication with research staff and/or APPs, and CHWs depending on study phase.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 22 May 2023
  • First Submitted that Met QC Criteria 22 May 2023
  • First Posted 1 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 August 2023
  • Last Update Posted 6 September 2023
  • Last Verified August 2023