NCT02532946

Brief Summary

This is a mixed methods study, incorporating a randomized controlled trial and a qualitative provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting reversible contraception in women seeking induced abortion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

3.3 years

First QC Date

March 9, 2015

Last Update Submit

April 12, 2017

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • Uptake, as measured by questionnaire, of long-acting reversible contraception (LARC) in 18-29 women seeking induced abortion

    Decision on contraceptive tool selected: LARC - Yes or No

    Up to 10 days

Secondary Outcomes (1)

  • Satisfaction with a web based tool as measured by a Likert scale

    Up to 10 days

Study Arms (2)

Bedsider counseling group

EXPERIMENTAL

Women exposed to: Bedsider.org counseling will be offered a computer or tablet at check-in to clinic. The outcome measure is measured at the patient's surgical abortion procedure appointment, or at medical abortion follow-up, which can range up to 10 days after enrollment

Behavioral: Bedsider.org counseling

Routine counseling group

NO INTERVENTION

Women were given counseling in the providers' usual practice style. They were given a card with Bedsider.org's web address along with the counseling.

Interventions

Bedsider.org counselingBEHAVIORAL

Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.

Bedsider counseling group

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Seeking medical or surgical pregnancy termination
  • weeks gestation or less

You may not qualify if:

  • Early pregnancy failure
  • Medical contraindications to any contraceptive methods as based on CDC Medical Eligibility Criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Sarita Soanlkar, MD MPH

    Hospital of the University of Pennsylvania Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

August 26, 2015

Study Start

August 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Publication in peer-reviewed journal