Reducing Alcohol Exposed Pregnancies
ConditionAlcohol Drinking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNew York University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years and above
Gestational age is 28 weeks or less
Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days
Disqualifiers
Under 18 years of age
Not pregnant or gestational age over 28 weeks
No recent alcohol use as assessed by self-report
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention condition, the usual prenatal care plus the alcohol intervention
BehavioralThe intervention is theory-driven, based on Motivational Enhancement Theory (MET), and uses motivational strategies to promote alcohol reduction.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Intervention condition, the usual prenatal care plus the alcohol interventionExperimental treatment 1 intervention
Group B: Comparison condition, usual prenatal care onlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Negative PEth among women
Proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy
Time frame
Through study completion, on average 6 months post-enrollmentSecondary outcomes
1
Pre-term births
Proportion of infants whose gestational age is \<37 weeks
Time frame
At birth2
Low birth weight
Proportion of infants who weighed less than 2500 grams at birth
Time frame
At birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
New York University
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
Health Resources in Action, Inc.
Collaborator
Purdue University
Collaborator
Source ClinicalTrials.gov