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NCT01643044 · ClinicalTrials.gov registry record · Phase 1
Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
A Phase 1 study, sponsored by Wayne State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01643044: Completed Phase 1 study, sponsored by Wayne State University.
NCT01643044 is a Phase 1 study that has completed, run by Wayne State University. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01643044, a Phase 1 study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include: 1. Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women. 2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women. 3. Evaluation of the efficacy of a computer-delivered brief intervention and use of tailored handouts to supplement the computer-based brief intervention focusing on alcohol use during pregnancy.
Primary Outcome
Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.
Interventions
- BEHAVIORAL Nutrition time control/placebo intervention
- BEHAVIORAL Computer-delivered, brief intervention on alcohol use
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01643044 record still lists
NCT01643044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Nutrition time control/placebo intervention is the first listed.
NCT01643044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01643044 about?
NCT01643044 is a clinical study titled "Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy". The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include: 1. Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-...
What is the current status of trial NCT01643044?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-04. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01643044?
The interventions under investigation include: Nutrition time control/placebo intervention (BEHAVIORAL), Computer-delivered, brief intervention on alcohol use (BEHAVIORAL).
Who is sponsoring clinical trial NCT01643044?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01643044's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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