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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote Medical Model (RMM)

    Other intervention

    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 intervention

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

  • SoC

    Other intervention

    SoC for Postpartum Hypertension

Treatment groups

6,030 Participants
are divided into 3 treatment groups
Group A: Standard of Care (SoC)Active comparator 1 intervention
Group B: Remote Medical Model (RMM)Experimental treatment 2 interventions
Group C: Community Health Model (CHM)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks
2

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.

Time frame
3 months

Secondary outcomes

1

Participant engagement

Engagement with a health care provider by 6 weeks will be assessed via self-report (collected via interview) and electronic medical records (indicator will be whether the participant was engaged in care at least once in the 6 weeks postpartum).

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator