Community Health Worker Assessment for Postpartum Health (NCT07572604) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Community Health Worker Assessment for Postpartum Health
500 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
16 Years – 44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.