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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Phone or video check-ins, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Follow-up telehealth visits will occur at least 1 time per week for the first 6 weeks and up to 12 weeks as needed."
  • "All participants will complete assessments and a blood pressure at intake along with telephone follow-up assessments at 6 weeks postpartum, 3 months and 6 months postpartum including a blood pressure check and mental health screen with EPDS and other study surveys at each time point."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (3)

CT

  • Yale New Haven Hospital · New Haven, CT 06520Rafael Pérez-Escamilla, PhD · Principal investigatorMore trials in New Haven

MA

NY