- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01945385
Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC) (LARC IUD)
July 25, 2014 updated by: University of Chicago
Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a brief, theory-based, video intervention prior to standard contraceptive counseling and women exposed to standard counseling alone.
Secondary: To identify predictors of immediate postabortal LARC uptake among all participants including the role of:
- Demographic and reproductive health history variables
- Baseline decisional balance, self-efficacy and stage of change for contraceptive initiation
Study Overview
Detailed Description
This is a randomized controlled trial evaluating the effect of a brief video intervention on postabortal uptake of long acting reversible contraception.
Study Type
Interventional
Enrollment (Actual)
193
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Planned Parenthood Near North
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Ages 18 - 29 Surgical abortion being performed the day of the study English speaking
Exclusion Criteria:
- Nonviable pregnancy Sexual assault Administered sedative medication Non English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video intervention
Participants will view a seven - minute theory-based video of patient testimonials about their own postabortal LARC uptake.
|
Brief 7 minute video of physician describing LARC methods followed by two patient testimonials about their own postabortal LARC experience.
|
|
No Intervention: Control
Patients will view a 7 minute video about stress management delivered by local psychologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postabortal LARC uptake
Time Frame: Immediate
|
Immediate uptake of IUD or contraceptive implant following surgical abortion
|
Immediate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived self efficacy surrounding LARC decision making
Time Frame: Baseline
|
Subject's own perception of her ability to uptake LARC in the postabortal period.
|
Baseline
|
|
Perceived decisional balance surrounding LARC decision making
Time Frame: Immediate
|
Subjects perceived pros and cons around starting a LARC method in the postabortal period
|
Immediate
|
|
Stage of behavioral change around LARC uptake
Time Frame: Immediate
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa Gilliam, MD, MPH, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
July 29, 2013
First Submitted That Met QC Criteria
September 17, 2013
First Posted (Estimate)
September 18, 2013
Study Record Updates
Last Update Posted (Estimate)
July 28, 2014
Last Update Submitted That Met QC Criteria
July 25, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 13-0185
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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