NCT05940688 (PᵌOPPY) is a NA clinical trial of Digital Health intervention in Pregnancy, sponsored by University of Alabama at Birmingham.

Who is sponsoring NCT05940688?

NCT05940688 is sponsored by University of Alabama at Birmingham.

What drugs are being tested in NCT05940688?

Interventions in NCT05940688: Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker.

What condition does NCT05940688 study?

NCT05940688 studies Pregnancy, Infants, Disparities.

Is NCT05940688 still recruiting?

NCT05940688 is currently completed. Last updated 20 October 2025.

Are results published for NCT05940688?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-20 · How we verify

NCT05940688: PᵌOPPY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study

Completed NA Results posted Last updated 20 October 2025

What this trial tests

NA trial testing Digital Health intervention in Pregnancy in 40 participants. Completed in 1 July 2024.

Timeline

17 July 2023

Primary endpoint
30 June 2024

1 July 2024

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	17 July 2023
Primary completion	30 June 2024
Estimated completion	1 July 2024
Sites	1 location across United States

Drugs / interventions tested

Digital Health intervention
Community Health Worker
Digital Health Intervention plus Community Health Worker

Conditions studied

Pregnancy — all drugs for Pregnancy →
Infants — all drugs for Infants →
Disparities — all drugs for Disparities →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 16 to 49, female only, with Pregnancy or Infants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participant Acceptance of Randomization Arm / Intervention Primary · 6 weeks postpartum

Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation."

Group	Value	95% CI
Digital Health Intervention (DHI)	8
Community Health Worker (CHW)	8
DHI Plus CHW	10
Usual Care	7
Digital Health Intervention (DHI)	1
Community Health Worker (CHW)	2
DHI Plus CHW	1
Usual Care	2
Digital Health Intervention (DHI)	0
Community Health Worker (CHW)	0
DHI Plus CHW	0
Usual Care	1

Outpatient Perinatal Care Visits Secondary · Randomization to study completion (up to 34 weeks)

Number of perinatal care visits

Group	Value	95% CI
Digital Health Intervention (DHI)	13	11 – 14
Community Health Worker (CHW)	9.5	6.5 – 11
DHI Plus CHW	9	4.5 – 10.5
Usual Care	12	10.5 – 12

Preterm Birth Secondary · At birth

Delivery of a neonate at less than 37 weeks

Group	Value	95% CI
Digital Health Intervention	2
Community Health Worker (CHW)	1
DHI Plus CHW	4
Usual Care	3
Digital Health Intervention	7
Community Health Worker (CHW)	7
DHI Plus CHW	7
Usual Care	7
Digital Health Intervention	0
Community Health Worker (CHW)	2
DHI Plus CHW	0
Usual Care	0

Neonatal Birthweight Secondary · At birth

Weight of neonate at birth

Group	Value	95% CI
Digital Health Intervention (DHI)	3160.0	2980 – 3480
Community Health Worker (CHW)	3150.0	2843.75 – 3577.5
DHI Plus CHW	2815.0	2690 – 2990
Usual Care	2920.0	2740 – 3060

Cesarean Delivery Secondary · At birth

Occurrence of a cesarean birth

Group	Value	95% CI
Digital Health Intervention	7
Community Health Worker (CHW)	5
DHI Plus CHW	3
Usual Care	3
Digital Health Intervention	2
Community Health Worker (CHW)	3
DHI Plus CHW	8
Usual Care	7
Digital Health Intervention	0
Community Health Worker (CHW)	2
DHI Plus CHW	0
Usual Care	0

Maternal Blood Transfusion Secondary · At birth

Transfusion of blood products

Group	Value	95% CI
Digital Health Intervention	1
Community Health Worker (CHW)	0
DHI Plus CHW	1
Usual Care	2
Digital Health Intervention	8
Community Health Worker (CHW)	8
DHI Plus CHW	10
Usual Care	8
Digital Health Intervention	0
Community Health Worker (CHW)	2
DHI Plus CHW	0
Usual Care	0

Breastfeeding Intent Secondary · Upon admission to the delivery-associated hospitalization

Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization

Group	Value	95% CI
Digital Health Intervention	2
Community Health Worker (CHW)	1
DHI Plus CHW	1
Usual Care	2
Digital Health Intervention	3
Community Health Worker (CHW)	3
DHI Plus CHW	3
Usual Care	1
Digital Health Intervention	3
Community Health Worker (CHW)	1
DHI Plus CHW	1
Usual Care	6
Digital Health Intervention	1
Community Health Worker (CHW)	3
DHI Plus CHW	2
Usual Care	1

Vaccination Rate Secondary · Pregnancy through 6 weeks postpartum / 6 weeks of life

The number of mothers who received Tdap and infants who received the Hep B vaccine.

Maternal TDAP

Group	Value	95% CI
Digital Health Intervention (DHI)	7
Community Health Worker (CHW)	4
DHI Plus CHW	5
Usual Care	5
Digital Health Intervention (DHI)	2
Community Health Worker (CHW)	6
DHI Plus CHW	6
Usual Care	5
Digital Health Intervention (DHI)	0
Community Health Worker (CHW)	0
DHI Plus CHW	0
Usual Care	0

Newborn Hep. B

Group	Value	95% CI
Digital Health Intervention (DHI)	6
Community Health Worker (CHW)	6
DHI Plus CHW	6
Usual Care	7
Digital Health Intervention (DHI)	3
Community Health Worker (CHW)	3
DHI Plus CHW	5
Usual Care	3
Digital Health Intervention (DHI)	0
Community Health Worker (CHW)	1
DHI Plus CHW	0
Usual Care	0

Maternal Postpartum Readmission Secondary · From discharge from the delivery-associated hospitalization to 6 weeks postpartum

Admission of the mother to the hospital after discharge from the delivery-associated hospitalization

Group	Value	95% CI
Digital Health Intervention (DHI)	0
Community Health Worker (CHW)	0
DHI Plus CHW	1
Usual Care	2
Digital Health Intervention (DHI)	9
Community Health Worker (CHW)	10
DHI Plus CHW	10
Usual Care	8

Neonatal Hospital Readmission Secondary · Birth to 6 weeks of life

Answer to the question " How is your baby doing?"

Group	Value	95% CI
Digital Health Intervention (DHI)	8
Community Health Worker (CHW)	8
DHI Plus CHW	7
Usual Care	7
Digital Health Intervention (DHI)	0
Community Health Worker (CHW)	0
DHI Plus CHW	0
Usual Care	1
Digital Health Intervention (DHI)	0
Community Health Worker (CHW)	0
DHI Plus CHW	4
Usual Care	1
Digital Health Intervention (DHI)	1
Community Health Worker (CHW)	2
DHI Plus CHW	0
Usual Care	1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

When HIPAA hurts: legal barriers to texting may reinforce healthcare disparities and disenfranchise vulnerable patients.
Lindsey D, Sinkey R, Travers C, Budhwani H, et al · · 2025 · cited 1× · PMID 39147791 · DOI 10.1038/s41372-024-02080-5

Verify or expand the search:

Other trials of Digital Health intervention

Trials testing the same drug.

NCT06510075 — Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial · NA · recruiting

Other recruiting trials for Pregnancy

Currently open trials in the same condition.

NCT07405723 — Arm Position and Blood Pressure Measurement Accuracy During Pregnancy · NA · recruiting
NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
NCT07385807 — Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Out · recruiting
NCT07226492 — Cash Transfers to Pregnant Women With HIV · NA · recruiting
NCT07435766 — Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy · NA · recruiting

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

NCT04922229 — Comparative Effectiveness in the Management of Irreversible Pulpitis · NA · not yet recruiting
NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05940688 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
Last refreshed: 20 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05940688.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing