NCT07271758

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Nutrient Deficiency

Interventions

Type	Name	Description
OTHER	DHA blood screening	Measure of DHA as percent of total fatty acids in red blood cells

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-08-01
• Completion: 2027-03-01
• First posted: 2025-12-09
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States