Contraceptive Choice at the Time of Uterine Evacuation

Contraception Clinical Trial

Official title:

Contraceptive Choice at the Time of Uterine Evacuation: A Randomized Controlled Pre-visit LARC Educational Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836561
• Other study ID #: 2016P000619
• Status: Completed
• Phase: N/A
• First received: June 17, 2016
• Last updated: April 17, 2017
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Scheduled for uterine evacuation

• Speaks English proficiently in order to understand the telephone conversation and the survey questions.

Exclusion Criteria:

• Previous participation in this study

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• Telephone message
A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Percentage of women who 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. Compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)	Day 1: Questionnaire administered prior to information session
Secondary	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	Percentage of women with a high score (cutpoint to be determined) on a 10-question LARC knowledge scale developed for this study. Compared between those who received the pre-visit information about contraception (intervention group) and those who did not (control group)	Day 1: Questionnaire administered prior to information session
Secondary	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	Percentage of women who report a LARC method as their preferred method of birth control, as assessed on a questionnaire created for this study. Compared between those who received the pre-visit information about contraception (intervention group) and those who did not (control group)	Day 1: Questionnaire administered prior to information session
Secondary	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	Percentage of women who report being somewhat or very interested in starting an implant or IUD, as assessed on a 4-point scale on a questionnaire created for this study. Compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)	Day 1: Questionnaire administered prior to information session
Secondary	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	Percentage of women who receive an implant or an IUD at the time of uterine evacuation, compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)	Day 1: Data abstraction to be performed after the subject's day 1 visit complete