Recruiting

Postpartum Hypertension

Sponsor:

Yale University

Code:

NCT05884190

Conditions

Postpartum Hypertension

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote Medical Model (RMM)

Community Health Model (CHM)

SoC

Study Details

Brief 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

Study ID

NCT05884190

Start date

Jun 12, 2023

Status verified date

Apr, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

6030 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard of Care (SoC)

Standard of Care for Postpartum Hypertension

experimental: Remote Medical Model (RMM)

Includes SoC plus RMM

experimental: Community Health Model (CHM)

Includes SoC, RMM plus CHM

Interventions

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

Community Health Model (CHM)

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

SoC

SoC for Postpartum Hypertension

Primary outcome measure

  • Change in mean postpartum systolic blood pressure (SBP) at 6 weeks [ Time Frame: 6 weeks ]
  • Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS). [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Rafael Pérez-Escamilla, PhD

8608052502rafael.perez-escamilla@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator:

Rafael Pérez-Escamilla, PhD

University of Massachusetts Memorial Health

Recruiting

Worcester, Massachusetts, United States, 01655

Oishei Children's Hospital University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

More Information

Sponsor

Yale University

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-04-09.