ContraceptionNCT02836561
Contraceptive Choice at the Time of Uterine Evacuation
A study testing Telephone message in people with Contraception, run by Planned Parenthood League of Massachusetts at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Telephone message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Scheduled for uterine evacuation
- Speaks English proficiently in order to understand the telephone conversation and the survey questions.
Who cannot join
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Conditions
- Contraception
- Being tested
- Telephone message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone messageOther
A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: Day 1: Data abstraction to be performed after the subject's day 1 visit complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, Principal investigator, Planned Parenthood League of Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836561
- Sponsor's protocol ID
- 2016P000619
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Present at conferences and publish results in peer reviewed journal
Publications
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.
PubMed 30012721
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Choice at the Time of Uterine Evacuation: A Randomized Controlled Pre-visit LARC Educational Intervention
- ClinicalTrials.gov ID
- NCT02836561
- Acronym / sponsor ID
- 2016P000619
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Message | Experimental | Other: Telephone messageParticipants who are randomized to the intervention message will receive contraception information in advance of their appointment that may be helpful in their decision-making. |
| Control Message | No intervention | –Participants who are randomized to the control message will receive appointment logistic information that may be a helpful reminder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Scheduled for uterine evacuation
- Speaks English proficiently in order to understand the telephone conversation and the survey questions.
Key exclusion criteria (1 listed)
- Previous participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone messageA pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation | Other | Intervention Message |
Primary outcome
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)
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Derived from this study: PubMed 30012721Roe 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.
- Individual participant dataSharing planned: Yes. Present at conferences and publish results in peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator, MD principal investigator
Planned Parenthood League of Massachusetts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone message in people with Contraception, run by Planned Parenthood League of Massachusetts at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.