NCT07271758

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

November 26, 2025

Last Update Submit

May 21, 2026

Conditions

Nutrient Deficiency

Keywords

DHAOmega-3 fatty acidsPregnancy

Outcome Measures

Primary Outcomes (1)

  • Screening uptake percentage

    Percent of eligible patients who receive DHA screening

    First 20 weeks of pregnancy

Other Outcomes (2)

  • Clinical staff training percentage

    60 days from activation

  • Docosahexaenoic Acid (DHA) status

    up to week 20 gestation

Study Arms (1)

DHA blood screening

EXPERIMENTAL

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

Other: DHA blood screening

Interventions

DHA blood screeningOTHER

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

DHA blood screening

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Katherine Sauder, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

April 13, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Sharing data is outside the scope of this pilot study.

Locations

US(1)