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

Conditions

• Postpartum Hypertension

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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) — OTHER
  Utilization of community health workers trained in a strength-based trauma informed dyadic evidence-based approach.
• SoC — OTHER
  SoC for Postpartum Hypertension

Study Details

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.

Key Dates

Start date

Jun 12, 2023

Status verified

Apr 2025

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

6,030 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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

Primary Outcome Measure

Change in mean postpartum systolic blood pressure (SBP) at 6 weeks [ Time Frame: 6 weeks ]

Central Contacts

• Rafael Pérez-Escamilla, PhD
  8608052502
  [email protected]

Locations (3)

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