Contraceptive Choice at the Time of Uterine Evacuation

April 17, 2017 updated by: Planned Parenthood League of Massachusetts

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood League of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 1: Questionnaire administered prior to the information session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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)
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
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)
Day 1: Data abstraction to be performed after the subject's day 1 visit complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Planned Parenthood League of Massachusetts

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Principal Investigator, MD, Planned Parenthood League of Massachusetts

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P000619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Present at conferences and publish results in peer reviewed journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings