Community Health Worker Assessment for Postpartum Health | NCT07572604

Studies
Community Health Worker Assessment for Postpartum Health

NCT07572604

Sponsor

University of Arkansas

Status

Not yet recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Postpartum Complication
Health Care Seeking Behavior

Interventions

CAREPATH
Standard of Care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Aug 31, 2029Estimated

Completion Date

Aug 31, 2029Estimated

First Submitted Date

May 1, 2026

First Submission Date that Met QC Criteria

May 1, 2026

First Posted Date

May 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2026

Last Update Posted Date

May 7, 2026Actual

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CAREPATH	Behavioral	Patients will received standard of care plus three telehealth visits with a perinatal community health worker.	CAREPATH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postpartum visit completion	Binary measure (yes/no) of visit completion	6 weeks postpartum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

44 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brett Rowland, MA	Contact	4797138661		mbrowland@uams.edu
Kenny Halloran	Contact	4797138661		khalloran@uams.edu

Overall Officials

Name	Affiliation	Role
Pearl McElfish, PhD	University of Arkansas	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010342	Patient Acceptance of Health Care

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided