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

NCT05884190 | Recruiting

• 2 other identifiers: 2000033779MMM-2021C2-23671
• Study Type: interventional
• Target: 6,030
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Change in mean postpartum systolic blood pressure (SBP) at 6 weeks

  Change in mean postpartum systolic blood pressure (SBP) at 6 weeks. A reduction in SBP indicates an improvement in postpartum hypertension.

  6 weeks

• Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS).

  EPDS is a 10-item validated scale that measures depressive symptoms and is designed for use with pregnant and postpartum women. Scoring: None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30). A reduction in depression severity at 3 months postpartum indicates a positive outcome.

  3 months

Secondary Outcomes (1)

• Participant engagement

  6 weeks

Study Arms (3)

Standard of Care (SoC)

ACTIVE COMPARATOR

Standard of Care for Postpartum Hypertension

Other: SoC

Remote Medical Model (RMM)

EXPERIMENTAL

Includes SoC plus RMM

Other: Remote Medical Model (RMM); Other: SoC

Community Health Model (CHM)

EXPERIMENTAL

Includes SoC, RMM plus CHM

Other: Remote Medical Model (RMM); Other: Community Health Model (CHM); Other: SoC

Interventions

Remote Medical Model (RMM) OTHER

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); Remote Medical Model (RMM)

Community Health Model (CHM) OTHER

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

Community Health Model (CHM)

SoC OTHER

SoC for Postpartum Hypertension

Community Health Model (CHM); Remote Medical Model (RMM); Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

University of Massachusetts Memorial Health

Worcester, Massachusetts, 01655, United States

RECRUITING

Oishei Children's Hospital University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Study Officials

• Rafael Pérez-Escamilla, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Pérez-Escamilla, PhD

CONTACT

8608052502; rafael.perez-escamilla@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study population will include adult postpartum women at least 18 yrs old that are at-risk for hypertension and/or poor mental health outcomes. This is a multi-site intervention study that follows a sequential stepped-wedge design with the 3 hospitals randomized to their start time for the first arm followed by the second and third arms.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)