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NCT01446653 · ClinicalTrials.gov registry record · NA
Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 232
- Enrollment target
NCT01446653: Completed NA study, sponsored by University of Virginia.
NCT01446653 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 232 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01446653, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 232 participants
- Enrollment target
Study Summary
The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.
Interventions
- BEHAVIORAL Video
- BEHAVIORAL Informational Brochure
- BEHAVIORAL Motivational Interviewing plus feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2007-02 |
| Est. Completion | 2011-09 |
| Phase | NA |
What the finished NCT01446653 record still lists
NCT01446653 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Video is the first listed.
NCT01446653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01446653 about?
NCT01446653 is a clinical study titled "Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial". The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rat...
What is the current status of trial NCT01446653?
This trial is currently completed. It is a NA study. The enrollment target is 232 participants. The study started on 2007-02. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01446653?
The interventions under investigation include: Video (BEHAVIORAL), Informational Brochure (BEHAVIORAL), Motivational Interviewing plus feedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT01446653?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01446653's enrollment target sits among peer trials
232 463rd of 2000 higher than 1,536 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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