Contraceptive Choice at the Time of Uterine Evacuation
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ClinicalTrials.gov Identifier: NCT02836561 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : April 18, 2017
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Condition or disease | Intervention/treatment | Phase |
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Contraception | Other: Telephone message | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 234 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Contraceptive Choice at the Time of Uterine Evacuation: A Randomized Controlled Pre-visit LARC Educational Intervention |
Study Start Date : | July 2016 |
Actual Primary Completion Date : | April 2017 |
Actual Study Completion Date : | April 2017 |

Arm | Intervention/treatment |
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Experimental: Intervention Message
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.
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Other: Telephone message
A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation |
No Intervention: Control Message
Participants who are randomized to the control message will receive appointment logistic information that may be a helpful reminder.
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- 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 [ Time Frame: Day 1: Questionnaire administered prior to the information session ]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)
- 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 [ Time Frame: Day 1: Questionnaire administered prior to information session ]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)
- 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 [ Time Frame: Day 1: Questionnaire administered prior to information session ]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)
- 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 [ Time Frame: Day 1: Questionnaire administered prior to information session ]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)
- 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 [ Time Frame: Day 1: Questionnaire administered prior to information session ]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)
- 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 [ Time Frame: Day 1: Data abstraction to be performed after the subject's day 1 visit complete ]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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836561
United States, Massachusetts | |
Planned Parenthood League of Massachusetts | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Principal Investigator, MD | Planned Parenthood League of Massachusetts |
Responsible Party: | Planned Parenthood League of Massachusetts |
ClinicalTrials.gov Identifier: | NCT02836561 |
Other Study ID Numbers: |
2016P000619 |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | April 18, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Present at conferences and publish results in peer reviewed journal |