Postpartum ComplicationCAREPATHNCT07572604
Community Health Worker Assessment for Postpartum Health
A study testing CAREPATH in people with Postpartum Complication and Health Care Seeking Behavior, run by University of Arkansas.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Complication, Health Care Seeking Behavior
- What is being tested?
- CAREPATH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-44 years old
- ≤ 38 weeks pregnant
- Ability to speak English, Spanish or Marshallese
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community Health Worker Assessment for Postpartum Health (CAREPATH)
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:
Read more
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.
- Being tested
- CAREPATH, Standard of Care
- Keywords
- Postpartum visit, Postpartum care, Postpartum complications
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREPATHBehavioural
Patients will received standard of care plus three telehealth visits with a perinatal community health worker.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum visit completion
Binary measure (yes/no) of visit completion
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ComplicationStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Pearl McElfish, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572604
- Sponsor's protocol ID
- 299245
- Acronym
- CAREPATH
- Status last verified
- Aug 2026
- First submitted
- 1 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker Assessment for Postpartum Health (CAREPATH)
- ClinicalTrials.gov ID
- NCT07572604
- Acronym / sponsor ID
- CAREPATH / 299245
- Keywords
- Postpartum visit, Postpartum care, Postpartum complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAREPATH | Experimental | Behavioral: CAREPATHParticipants 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. |
| Standard of Care (SoC) | Active comparator | Other: Standard of CareParticipants in the SoC arm will receive education on symptoms of postpartum complications and assistance scheduling their postpartum visit with their healthcare provider. |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 16-44 years old
- ≤ 38 weeks pregnant
- Ability to speak English, Spanish or Marshallese
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAREPATHPatients will received standard of care plus three telehealth visits with a perinatal community health worker. | Behavioural | CAREPATH |
| Standard of CarePatients 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. | Other | Standard of Care (SoC) |
Primary outcome
Postpartum visit completion
Time frame: 6 weeks postpartum
Binary measure (yes/no) of visit completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pearl McElfish, PhD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
A study testing CAREPATH in people with Postpartum Complication and Health Care Seeking Behavior, run by University of Arkansas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Rowland, MA (4797138661, mbrowland@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum visit completion (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.