AbortionLARC IUDNCT01945385
Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC)
A study testing Video intervention in people with Abortion, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion
- What is being tested?
- Video intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 - 29 Surgical abortion being performed the day of the study English speaking
Who cannot join
- Nonviable pregnancy Sexual assault Administered sedative medication Non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Near North
Chicago, Illinois, 60611
About this study
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
Read the detailed description
This is a randomized controlled trial evaluating the effect of a brief video intervention on postabortal uptake of long acting reversible contraception.
- Conditions
- Abortion
- Being tested
- Video intervention
- Keywords
- Abortion, LARC, Contraception, IUD, Contraceptive implant, behavioral change, video intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video interventionBehavioural
Brief 7 minute video of physician describing LARC methods followed by two patient testimonials about their own postabortal LARC experience.
| Study group | Role | What they receive |
|---|---|---|
| Video intervention | Experimental | Participants will view a seven - minute theory-based video of patient testimonials about their own postabortal LARC uptake. Receives: Behavioral: Video intervention |
| Control | No intervention | Patients will view a 7 minute video about stress management delivered by local psychologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postabortal LARC uptake
Immediate uptake of IUD or contraceptive implant following surgical abortion
Measured: Immediate
Secondary outcomes (3)
Perceived self efficacy surrounding LARC decision making
Subject's own perception of her ability to uptake LARC in the postabortal period.
Measured: Baseline
Perceived decisional balance surrounding LARC decision making
Subjects perceived pros and cons around starting a LARC method in the postabortal period
Measured: Immediate
Stage of behavioral change around LARC uptake
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Melissa Gilliam, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945385
- Sponsor's protocol ID
- 13-0185
- Acronym
- LARC IUD
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2013
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC)
- ClinicalTrials.gov ID
- NCT01945385
- Acronym / sponsor ID
- LARC IUD / 13-0185
- Conditions
- Abortion
- Keywords
- Abortion, LARC, Contraception, IUD, Contraceptive implant, behavioral change, video intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video intervention | Experimental | Behavioral: Video interventionParticipants will view a seven - minute theory-based video of patient testimonials about their own postabortal LARC uptake. |
| Control | No intervention | –Patients will view a 7 minute video about stress management delivered by local psychologist. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ages 18 - 29 Surgical abortion being performed the day of the study English speaking
Key exclusion criteria (1 listed)
- Nonviable pregnancy Sexual assault Administered sedative medication Non English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video interventionBrief 7 minute video of physician describing LARC methods followed by two patient testimonials about their own postabortal LARC experience. | Behavioural | Video intervention |
Primary outcome
Postabortal LARC uptake
Time frame: Immediate
Immediate uptake of IUD or contraceptive implant following surgical abortion
3 secondary outcomes
Perceived self efficacy surrounding LARC decision making
Time frame: Baseline
Perceived decisional balance surrounding LARC decision making
Time frame: Immediate
Stage of behavioral change around LARC uptake
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Gilliam, MD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video intervention in people with Abortion, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postabortal LARC uptake (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.