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Not Yet Recruiting NCT07572604

Community Health Worker Assessment for Postpartum Health

Conditions: Postpartum Complication, Health Care Seeking Behavior

Sex: Female
Ages: 16 Years – 44 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 500
Sponsor: University of Arkansas

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07572604). StuddyBuddy aggregates publicly available trial information.