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Not yet recruiting NCT07572604

Community Health Worker Assessment for Postpartum Health

No phase Interventional Postpartum Complication Health Care Seeking Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAREPATH, Standard of Care.
Who it may be relevant to
Registry conditions: Postpartum Complication, Health Care Seeking Behavior. Basic parameters: 16 years — 44 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Community Health Worker Assessment for Postpartum Health (CAREPATH)

Overview

The goal of this randomized controlled trial is to compare the CAREPATH intervention with standard of care on postpartum outcomes among up to 500 postpartum individuals. The CAREPATH includes 3 postpartum telehealth visits from a perinatal CHW. The study will address the following aims: Aim 1: Compare: A) CARE PATH and B) standard of care among postpartum individuals on: Aim 1.A: postpartum visit completion. * Hypothesis 1.A: Patients assigned to the CARE PATH will have higher completion of their postpartum visit compared to those receiving standard of care. Aim 1.B: early detection of postpartum complications. * Hypothesis 1.B: Patients assigned to the CARE PATH will be more likely to experience early detection of postpartum complications that arise compared to those receiving standard of care. Aim 1.C: hospital readmission and ED visits postpartum. * Hypothesis 1.C: Patients assigned to the CARE PATH will be less likely to have hospital readmission or an ED visit compared to those receiving standard of care. Aim 2: Explore the impact of A) CARE PATH and B) standard of care on reproductive life planning/contraceptive counseling. * Hypothesis 2: Patients assigned to the CARE PATH will be more likely to report reproductive life planning/contraceptive counseling.

Interventions

  • Behavioral CAREPATH
    Patients will received standard of care plus three telehealth visits with a perinatal community health worker.
  • Other Standard of Care
    Patients will receive standard of care which includes: education on postpartum complications symptoms and when to call their healthcare provider, assistance scheduling their postpartum visit, and any healthcare deemed necessary by providers.

Primary outcome measures

  • Postpartum visit completion [Time frame: 6 weeks postpartum]

Eligibility criteria

Inclusion criteria

  • Age 16-44 years old
  • ≤ 38 weeks pregnant
  • Ability to speak English, Spanish or Marshallese

Exclusion criteria

  • Type 1 diabetes on an insulin pump followed closely by endocrinology
  • Uncontrolled Type 2 diabetes
  • End stage renal disease followed closely by nephrology
  • ICU admission at any point during pregnancy or delivery hospitalization
  • Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
  • Incarceration
  • Mental disability limiting decision-making capacity
  • Uncontrolled chronic hypertension
  • HELLP syndrome during pregnancy
  • Sickle cell disease
  • Maternal heart condition or heart disease
  • Opioid use disorder
  • Lupus
  • Thrombophilia or blood clots
  • Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07572604 · 299245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗