Contraceptive Choice at the Time of Uterine Evacuation

NCT02836561 | Completed

• 1 other identifier: 2016P000619
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to investigate whether a pre-visit telephone intervention could increase awareness of long-acting reversible contraception (LARC) availability at the time of uterine evacuation.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Knowledge that LARC can start at uterine evacuation: Percentage of women who report that LARC methods are available to start at the time of uterine evacuation, as assessed on a questionnaire created for this study

  Percentage of women who know that the implant and IUD are available to start at the time of uterine evacuation, as assessed on a questionnaire created for this study. Compared between those who receive the pre-visit information (intervention group) and those who do not receive this information (control group)

  Day 1: Questionnaire administered prior to the information session

Secondary Outcomes (5)

• Intervention utility: Percentage of women who report that receiving information about contraception before their appointment was either very useful or somewhat useful, as assessed on a 4-point scale on a questionnaire created for this study

  Day 1: Questionnaire administered prior to information session

• General LARC knowledge: Percentage of women with a high score (cutpoint to be determined) on a 10-question LARC knowledge scale developed for this study

  Day 1: Questionnaire administered prior to information session

• Intent to use LARC: Percentage of women who report a LARC method as their preferred method of birth control, as assessed on a questionnaire created for this study

  Day 1: Questionnaire administered prior to information session

• LARC stage of change: Percentage of women who report being somewhat or very interested in starting a LARC method, as assessed on a 4-point scale on a questionnaire created for this study

  Day 1: Questionnaire administered prior to information session

• Uptake of LARC at time of uterine evacuation: Percentage of women who receive a LARC method at the time of uterine evacuation, as documented within the electronic medical record

  Day 1: Data abstraction to be performed after the subject's day 1 visit complete

Study Arms (2)

Intervention Message

EXPERIMENTAL

Participants who are randomized to the intervention message will receive contraception information in advance of their appointment that may be helpful in their decision-making.

Other: Telephone message

Control Message

NO INTERVENTION

Participants who are randomized to the control message will receive appointment logistic information that may be a helpful reminder.

Interventions

Telephone message OTHER

A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation

Intervention Message

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Scheduled for uterine evacuation
• Speaks English proficiently in order to understand the telephone conversation and the survey questions.

You may not qualify if:

• Previous participation in this study

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Roe AH, Fortin J, Gelfand D, Janiak E, Maurer R, Goldberg A. Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial. BMJ Sex Reprod Health. 2018 Jul;44(3):187-192. doi: 10.1136/bmjsrh-2017-200023. Epub 2018 May 18.

  PMID: 30012721 DERIVED

Study Officials

• Principal Investigator, MD

  Planned Parenthood League of Massachusetts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: July 19, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)