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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07271758
Acronym
PROmega
Enrollment
650
Registered
2025-12-09
Start date
2026-04-13
Completion date
2027-12-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrient Deficiency

Keywords

DHA, Omega-3 fatty acids, Pregnancy

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.

Interventions

OTHERDHA blood screening

Measure of DHA as percent of total fatty acids in red blood cells

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Screening uptake percentageFirst 20 weeks of pregnancyPercent of eligible patients who receive DHA screening

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine Sauder, PhD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026