NCT01945385

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

July 29, 2013

Last Update Submit

July 25, 2014

Conditions

Abortion

Keywords

AbortionLARCContraceptionIUDContraceptive implantbehavioral changevideo intervention

Outcome Measures

Primary Outcomes (1)

  • Postabortal LARC uptake

    Immediate uptake of IUD or contraceptive implant following surgical abortion

    Immediate

Secondary Outcomes (3)

  • Perceived self efficacy surrounding LARC decision making

    Baseline

  • Perceived decisional balance surrounding LARC decision making

    Immediate

  • Stage of behavioral change around LARC uptake

    Immediate

Study Arms (2)

Video intervention

EXPERIMENTAL

Participants will view a seven - minute theory-based video of patient testimonials about their own postabortal LARC uptake.

Behavioral: Video intervention

Control

NO INTERVENTION

Patients will view a 7 minute video about stress management delivered by local psychologist.

Interventions

Video interventionBEHAVIORAL

Brief 7 minute video of physician describing LARC methods followed by two patient testimonials about their own postabortal LARC experience.

Video intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18 - 29 Surgical abortion being performed the day of the study English speaking

You may not qualify if:

  • Nonviable pregnancy Sexual assault Administered sedative medication Non English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood Near North

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Melissa Gilliam, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

September 18, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

US(1)