Termination of PregnancyNCT01811056
Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
A study testing Mifepristone in people with Termination of Pregnancy, run by Gynuity Health Projects at 3 sites in United States.
Trial summary
This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination. 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
- Termination of Pregnancy
- What is being tested?
- Mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Jul 2014
- 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
- Women 18 years and older
- seeking medical abortion services
- in general good health
- assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken
- eligible for medical abortion according to clinician and center standards.
Who cannot join
- will be followed up by beta HCG and not ultrasound
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Planned Parenthood of Northern New England
Barre, Burlington, Rutland, Vermont
Planned Parenthood of New York City
New York, New York
Planned Parenthood of the Great Northwest
Seattle, Washington
About this study
This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.
Read the detailed description
This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.
- Conditions
- Termination of Pregnancy
- Being tested
- Mifepristone
- Keywords
- medical abortion, mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called mifeprex
Mifepristone use outside of the center
| Study group | Role | What they receive |
|---|---|---|
| In-Center Use of Mifepristone | No intervention | Participants who choose to take mifepristone in the center |
| Out-of-Center Use of Mifepristone | Experimental | Participants who choose to take the mifepristone outside of the center Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who would choose outside of center administration of mifepristone again
Measured: 1-2 weeks
Proportion of participants who would recommend outside-of-center administration to a friend
Measured: 1-2 weeks
Secondary outcomes (4)
Proportion of women who select outside-of-clinic use of mifepristone
Measured: 1-2 weeks
Success Rates/Method Failure
Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study
Measured: 1-2 weeks
Adherence
Did not take complete therapy Mifepristone not taken at scheduled time Mifepristone not taken within 63 days L.M.P. Misoprostol not taken within 48 hours of mifepristone administration Did not return for confirmation of outcome
Measured: 1-2 weeks
Provider-related outcomes
Unscheduled visits to center Unscheduled calls to center/clinician on-call Provider satisfaction- better than center mifepristone, equivalent, or worse; impact on workload; impact on quality of care
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Termination of PregnancyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811056
- Sponsor's protocol ID
- 1006
- Status last verified
- Aug 2015
- First submitted
- 11 Mar 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Swica Y, Chong E, Middleton T, Prine L, Gold M, Schreiber CA, Winikoff B. Acceptability of home use of mifepristone for medical abortion. Contraception. 2013 Jul;88(1):122-7. doi: 10.1016/j.contraception.2012.10.021. Epub 2012 Nov 21.
PubMed 23177917Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2.
PubMed 26142620
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
- ClinicalTrials.gov ID
- NCT01811056
- Acronym / sponsor ID
- 1006
- Conditions
- Termination of Pregnancy
- Keywords
- medical abortion, mifepristone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Mar 2013 (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.
This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.
Detailed description
This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Center Use of Mifepristone | No intervention | –Participants who choose to take mifepristone in the center |
| Out-of-Center Use of Mifepristone | Experimental | Drug: MifepristoneParticipants who choose to take the mifepristone outside of the center |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women 18 years and older
- seeking medical abortion services
- in general good health
- assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken
- eligible for medical abortion according to clinician and center standards.
Key exclusion criteria (1 listed)
- will be followed up by beta HCG and not ultrasound
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 |
|---|---|---|
| MifepristoneAlso: mifeprexMifepristone use outside of the center | Drug | Out-of-Center Use of Mifepristone |
Primary outcome
Proportion of participants who would choose outside of center administration of mifepristone again
Time frame: 1-2 weeks
Proportion of participants who would recommend outside-of-center administration to a friend
Time frame: 1-2 weeks
4 secondary outcomes
Proportion of women who select outside-of-clinic use of mifepristone
Time frame: 1-2 weeks
Success Rates/Method Failure
Time frame: 1-2 weeks
Adherence
Time frame: 1-2 weeks
Provider-related outcomes
Time frame: 1-2 weeks
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 13 Aug 2015.
- Background: PubMed 23177917Swica Y, Chong E, Middleton T, Prine L, Gold M, Schreiber CA, Winikoff B. Acceptability of home use of mifepristone for medical abortion. Contraception. 2013 Jul;88(1):122-7. doi: 10.1016/j.contraception.2012.10.021. Epub 2012 Nov 21.
- Results publication: PubMed 26142620Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2.
- Gynuity Health Projects WebsiteLink provided by the sponsor.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone in people with Termination of Pregnancy, run by Gynuity Health Projects at 3 sites 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 5 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Proportion of participants who would choose outside of center administration of mifepristone again (time frame: 1-2 weeks). The study lists 2 primary outcomes in all. 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 NCT01811056, which also lists 2 linked publications.
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 13 Aug 2015.