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NCT05884190Recruiting

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

Community-based, Family-centered, Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
6030 (estimated)
First submitted
22 May 2023
Start date
12 Jun 2023
Primary completion date
31 Oct 2027
Lead sponsor
Yale University
NCT number
NCT05884190

What you commit to

  • Study type: Interventional
  • Planned participants: 6030
  • From 12 Jun 2023 to the primary completion date, 31 Oct 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder)
  • Severe medical complications that don't allow a mother to do the study effectively (for example, active treatment for cancer, dialysis etc. )

Age

  • Gestational age \<24 weeks;

Other

  • Multifetal pregnancy (since are they at increased risk for key outcomes)
  • 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
  • Plans to move out of the state within 6 months
  • Incapable of consent
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oishei Children's Hospital University at Buffalo
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
Yale New Haven Hospital
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
University of Massachusetts Memorial Health
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.