Pregnancy ComplicationsP3OPPYNCT06510075
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
A study testing Digital Health intervention, Community Health Worker and Digital Health Intervention plus Community Health Worker in people with Pregnancy Complications and Maternal Distress, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Pregnancy Complications, Maternal Distress, Adverse Birth Outcomes
- What is being tested?
- Digital Health intervention, Community Health Worker and Digital Health Intervention plus Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Aug 2027
- 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 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Self Identifies as Non-Hispanic Black
- Between 16-49 years old
- Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
- Live singleton or dichorionic twin gestation
- Dating sonogram at <23 weeks gestation,
- Area Deprivation Index (ADI) National 4th or 5th Quintile
Show all 9Show fewer
- Planning to deliver at UAB Hospital
- Speaks and writes in English
- No indication for delivery at the time of enrollment
Who cannot join
- Declines randomization
- Speaks or writes in languages other than English
- Currently incarcerated
- Fetal demise diagnosed prior to enrollment
- Known major structural chromosomal abnormalities prior to enrollment
- Participated in POPPY Pilot
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.
Read the detailed description
The aim of this trial is to assess whether an existing Digital Heath Intervention (DHI) and/or a Community Health Worker (CHW) Intervention will reduce adverse maternal and perinatal outcomes. A 2 x 2 factorial randomized controlled trial of Non-Hispanic Black (NHB) patients living in high area deprivation index (ADI) communities will be conducted. Participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (PNC) alone, or 2) standard PNC plus DHI, or 3) standard PNC plus CHW, or 4) standard PNC, plus DHI and CHW.
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond.
- Being tested
- Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker
- Keywords
- Pregnancy outcomes, Health inequities
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health interventionBehavioural
Also called DHI
Health care information delivered via a link in a text message that is then opened in a secure browser.
Community Health WorkerBehavioural
Also called CHW
Health care information delivered via CHW.
Digital Health Intervention plus Community Health WorkerBehavioural
Also called DHI plus CHW
Health care information delivered via DHI plus CHW
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Intervention (DHI) | Experimental | This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. Receives: Behavioral: Digital Health intervention |
| Community health worker (CHW) | Experimental | Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board Receives: Behavioral: Community Health Worker |
| DHI Plus CHW | Experimental | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. Receives: Behavioral: Digital Health Intervention plus Community Health Worker |
| Usual Care | No intervention | This group will receive routine prenatal care services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted Adverse Outcome Score (WAOS)
WAOS, calculated by adding the weights of all adverse events divided by the total number of deliveries.
Maternal death=750, Neonatal death=400, Uterine rupture=100, Maternal ICU Admission=65, Birth trauma=60, Unanticipated operative procedure=40, NICU Admission=35, 5-minute Apgar <7=25, Maternal blood transfusion=20, and 4th degree perineal lacerations=5.
Measured: [Time Frame: From randomization to 6 weeks postpartum]
Secondary outcomes (8)
Outpatient Prenatal Care Visits
Number of outpatient prenatal care and postpartum visits
Measured: Duration of pregnancy through 6 weeks postpartum
Preterm Birth
Delivery of a neonate at less than 37 weeks
Measured: At birth
Neonatal birthweight
Weight of neonate at birth
Measured: At birth
Cesarean delivery
Occurrence of a cesarean birth
Measured: At birth
Maternal blood transfusion
Transfusion of blood products
Measured: Duration of pregnancy through 6 weeks postpartum
Breastfeeding intent
Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization
Measured: From randomization to delivery of the infant(s)
Maternal postpartum readmission
Admission of the mother to the hospital after discharge from the delivery-associated hospitalization
Measured: From discharge from the delivery-associated hospitalization to 6 weeks postpartum
Neonatal hospital readmission
Admission of a neonate to the hospital after discharge from the hospital after birth
Measured: Birth to 6 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is a randomized trial (n=400) randomizing eligible participants to usual care (n=100), or usual care plus a digital health intervention (n=100), or usual care plus a community health worker intervention (n=100), or usual care plus both a digital health intervention and a community health worker intervention (n=100).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, ConnectionHealth, Memora Health
- Responsible party
- Principal investigator, Rachel Sinkey, University of Alabama at Birmingham
- Investigators
- Rachel Sinkey, MD, Principal investigator, University of Alabama at BirminghamWally Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510075
- Sponsor's protocol ID
- IRB-300013085
- Other IDs
- 22HERNPMI985239
- Acronym
- P3OPPY
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06510075
- Acronym / sponsor ID
- P3OPPY / IRB-300013085
- Keywords
- Pregnancy outcomes, Health inequities
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Heart Association, ConnectionHealth, Memora Health
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Jul 2024 (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 PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.
Detailed description
The aim of this trial is to assess whether an existing Digital Heath Intervention (DHI) and/or a Community Health Worker (CHW) Intervention will reduce adverse maternal and perinatal outcomes. A 2 x 2 factorial randomized controlled trial of Non-Hispanic Black (NHB) patients living in high area deprivation index (ADI) communities will be conducted. Participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (PNC) alone, or 2) standard PNC plus DHI, or 3) standard PNC plus CHW, or 4) standard PNC, plus DHI and CHW.
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- Study is a randomized trial (n=400) randomizing eligible participants to usual care (n=100), or usual care plus a digital health intervention (n=100), or usual care plus a community health worker intervention (n=100), or usual care plus both a digital health intervention and a community health worker intervention (n=100).
| Arm | Type | Receives |
|---|---|---|
| Digital Health Intervention (DHI) | Experimental | Behavioral: Digital Health interventionThis group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. |
| Community health worker (CHW) | Experimental | Behavioral: Community Health WorkerIndividuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board |
| DHI Plus CHW | Experimental | Behavioral: Digital Health Intervention plus Community Health WorkerThis group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
| Usual Care | No intervention | –This group will receive routine prenatal care services. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Self Identifies as Non-Hispanic Black
- Between 16-49 years old
- Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
- Live singleton or dichorionic twin gestation
- Dating sonogram at <23 weeks gestation,
Key exclusion criteria (6 listed)
- Declines randomization
- Speaks or writes in languages other than English
- Currently incarcerated
- Fetal demise diagnosed prior to enrollment
- Known major structural chromosomal abnormalities prior to enrollment
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 |
|---|---|---|
| Digital Health interventionAlso: DHIHealth care information delivered via a link in a text message that is then opened in a secure browser. | Behavioural | Digital Health Intervention (DHI) |
| Community Health WorkerAlso: CHWHealth care information delivered via CHW. | Behavioural | Community health worker (CHW) |
| Digital Health Intervention plus Community Health WorkerAlso: DHI plus CHWHealth care information delivered via DHI plus CHW | Behavioural | DHI Plus CHW |
Primary outcome
Weighted Adverse Outcome Score (WAOS)
Time frame: [Time Frame: From randomization to 6 weeks postpartum]
WAOS, calculated by adding the weights of all adverse events divided by the total number of deliveries. Maternal death=750, Neonatal death=400, Uterine rupture=100, Maternal ICU Admission=65, Birth trauma=60, Unanticipated operative procedure=40, NICU Admission=35, 5-minute Apgar <7=25, Maternal blood transfusion=20, and 4th degree perineal lacerations=5.
8 secondary outcomes
Outpatient Prenatal Care Visits
Time frame: Duration of pregnancy through 6 weeks postpartum
Preterm Birth
Time frame: At birth
Neonatal birthweight
Time frame: At birth
Cesarean delivery
Time frame: At birth
Maternal blood transfusion
Time frame: Duration of pregnancy through 6 weeks postpartum
Breastfeeding intent
Time frame: From randomization to delivery of the infant(s)
Maternal postpartum readmission
Time frame: From discharge from the delivery-associated hospitalization to 6 weeks postpartum
Neonatal hospital readmission
Time frame: Birth to 6 weeks of life
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 30 Oct 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. This study is not recruiting at the moment.
Rachel Sinkey, MD principal investigator
University of Alabama at Birmingham
Wally Carlo, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health intervention, Community Health Worker and Digital Health Intervention plus Community Health Worker in people with Pregnancy Complications and Maternal Distress, run by University of Alabama at Birmingham at 1 site in United States.
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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weighted Adverse Outcome Score (WAOS) (time frame: [Time Frame: From randomization to 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 30 Oct 2026.