Clinical Trial

Reducing Alcohol Exposed Pregnancies

Recruiting
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Summary
The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-03-10; most recent amendment 2026-04-08.
Status change: Not Yet Recruiting → Recruiting 2024-06-24
Trial Details
NCT Number NCT05766761
Lead Sponsor New York University
Collaborators: The University of Texas Health Science Center, Houston, Health Resources in Action, Inc., Purdue University
Conditions Alcohol Drinking
Enrollment 600 participants
Start Date 2024-04-15
Primary Completion 2026-09 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-13