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Enrolling by Invitation

NCT Number: NCT07271758

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

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.

Enrolling by Invitation

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Key information

Conditions

Nutrient Deficiency

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA blood screening

Other

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

Primary outcomes

  1. Screening uptake percentage

    Time frame: First 20 weeks of pregnancy

    Percent of eligible patients who receive DHA screening

Other outcomes

  1. Clinical staff training percentage

    Time frame: 60 days from activation

    Percent of eligible clinical staff completing training

  2. Docosahexaenoic Acid (DHA) status

    Time frame: up to week 20 gestation

    Percent of screened patients with low DHA (<5% of total fatty acids)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: PROmega

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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