PROmega Pilot Study of Clinic-based DHA Blood Screening i... | NCT07271758

Studies
PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy

NCT07271758

Sponsor

Wake Forest University Health Sciences

Status

Enrolling by invitation

Last Update Posted

May 26, 2026Actual

Enrollment

650Estimated

Phase

Not Applicable

Conditions

Nutrient Deficiency

Interventions

DHA blood screening

Countries

United States

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

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2026Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 26, 2025

First Submission Date that Met QC Criteria

Nov 26, 2025

First Posted Date

Dec 9, 2025Actual

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 21, 2026

Last Update Posted Date

May 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This pilot study will explore feasibility of routine implementation of the recommended blood-based screening of DHA status in early pregnancy in routine clinical care.

Detailed Description

This pilot study will be conducted within the Atrium Health Wake Forest Baptist general academic obstetric practice that serves patients in six clinic locations in the Winston-Salem area. The study will train clinical staff on the prenatal omega-3 evidence; work with Epic IT to add the DHA blood test to the early prenatal lab order set; provide screening results with interpretation to patients and clinicians via Epic; monitor uptake of screening and viewing of results; and review screening results and characteristics of screened patients. This pilot data will inform the design of a cluster randomized trial to compare DHA blood screening with US usual care on preterm birth outcomes.

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

650Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DHA blood screening	Experimental	Measurement of DHA as percent of total fatty acids in red blood cells	Other: DHA blood screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DHA blood screening	Other	Measure of DHA as percent of total fatty acids in red blood cells	DHA blood screening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Screening uptake percentage	Percent of eligible patients who receive DHA screening	First 20 weeks of pregnancy

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Clinical staff training percentage	Percent of eligible clinical staff completing training	60 days from activation
Docosahexaenoic Acid (DHA) status	Percent of screened patients with low DHA (<5% of total fatty acids)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients initiating prenatal care at participating clinics who are eligible for early pregnancy blood testing per American College of Obstetricians and Gynecologists (ACOG) standards

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katherine Sauder, PhD	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences		Winston-Salem	North Carolina	27157	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Sharing data is outside the scope of this pilot study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided