NCT07572604

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Postpartum ComplicationHealth Care Seeking Behavior

Keywords

Postpartum visitPostpartum carePostpartum complications

Outcome Measures

Primary Outcomes (1)

  • Postpartum visit completion

    Binary measure (yes/no) of visit completion

    6 weeks postpartum

Study Arms (2)

CAREPATH

EXPERIMENTAL

Participants in the CAREPATH arm will receive standard of care plus three telehealth visits from a perinatal community health worker during the first six weeks of the postpartum period. During the visits, participants will be screened for postpartum complications using a symptom monitoring checklist that covers urgent maternal warning signs, as well as anxiety and depression.

Behavioral: CAREPATH

Standard of Care (SoC)

ACTIVE COMPARATOR

Participants in the SoC arm will receive education on symptoms of postpartum complications and assistance scheduling their postpartum visit with their healthcare provider.

Other: Standard of Care

Interventions

CAREPATHBEHAVIORAL

Patients will received standard of care plus three telehealth visits with a perinatal community health worker.

CAREPATH
Standard of CareOTHER

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.

Standard of Care (SoC)

Eligibility Criteria

Age16 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Pearl McElfish, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett Rowland, MA

CONTACT

4797138661mbrowland@uams.edu

Kenny Halloran

CONTACT

4797138661khalloran@uams.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

May 7, 2026

Record last verified: 2026-05