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

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Nutrient Deficiency

Treatments: Other: DHA blood screening

Study type: Interventional

Funder types: Other

Identifiers

NCT07271758

IRB00140664

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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650 participants in 1 patient group

DHA blood screening

Experimental group

Description:

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

Treatment:

Other: DHA blood screening