Abortion, First TrimesterNCT02219100
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
A study testing Home administration of 200 mg mifepristone in people with Abortion, First Trimester, run by Gynuity Health Projects at 5 sites in 2 countries.
Trial summary
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Abortion, First Trimester
- What is being tested?
- Home administration of 200 mg mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2010to Nov 2011
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older
- Good general health
- Living or working close to the study site
- Intrauterine pregnancy less than 64 days gestation
- Willing and able to sign consent forms
- Eligible for medical abortion according to the clinician's assessment
Show all 9Show fewer
- Ready access to a telephone and emergency transportation
- Willing to provide an address and/or telephone number for purposes of follow-up
- Agree to comply with the study procedures and visit schedule
Who cannot join
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- IUD in place (IUD must be removed first)
- Chronic renal failure
- Concurrent long-term corticosteroid therapy
- History of allergy to mifepristone, misoprostol or other prostaglandin
- Hemorrhagic disorders or concurrent anticoagulant therapy
- Inherited porphyrias
- Other serious physical or mental health conditions
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Azerbaijan3 sites
Antenatal Clinic
Ganja
Family Planning Center
Ganja
Gynecology Department of the Central Regional Hospital
Zaqatala
About this study
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.
- Conditions
- Abortion, First Trimester
- Being tested
- Home administration of 200 mg mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home administration of 200 mg mifepristoneDrug
Home administration of 200 mg mifepristone
| Study group | Role | What they receive |
|---|---|---|
| Home administration of mifepristone | Experimental | This arm consisted of women who chose home administration of 200 mg mifepristone. Receives: Drug: Home administration of 200 mg mifepristone |
| Clinic administration of mifepristone | No intervention | This arm consisted of women who underwent clinic administration of 200 mg mifepristone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abortions that are complete without surgical intervention (unit: percent).
Percentage of women with complete abortion without the need of a surgical intervention.
Measured: 15 days
Secondary outcomes (1)
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).
Woman's satisfaction with her medical abortion procedure and side effects experienced.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, First TrimesterStudies 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
- 613 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 ProjectsRena Bagirova, MD, Principal investigator, Antenatal ClinicMehriban Huseynova, MD, Principal investigator, Gynecology Department of the Central Regional HospitalAram Avalyan, MD, Principal investigator, Vanadzor Hospital #1Alla Minasyan, MD, Principal investigator, Gyumri Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219100
- Sponsor's protocol ID
- 1.2.3.1
- Status last verified
- Aug 2014
- First submitted
- 29 Jul 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
- ClinicalTrials.gov ID
- NCT02219100
- Acronym / sponsor ID
- 1.2.3.1
- Conditions
- Abortion, First Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Aug 2014 (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 examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.
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 |
|---|---|---|
| Home administration of mifepristone | Experimental | Drug: Home administration of 200 mg mifepristoneThis arm consisted of women who chose home administration of 200 mg mifepristone. |
| Clinic administration of mifepristone | No intervention | –This arm consisted of women who underwent clinic administration of 200 mg mifepristone. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 years or older
- Good general health
- Living or working close to the study site
- Intrauterine pregnancy less than 64 days gestation
- Willing and able to sign consent forms
Key exclusion criteria (8 listed)
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- IUD in place (IUD must be removed first)
- Chronic renal failure
- Concurrent long-term corticosteroid therapy
- History of allergy to mifepristone, misoprostol or other prostaglandin
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 |
|---|---|---|
| Home administration of 200 mg mifepristoneHome administration of 200 mg mifepristone | Drug | Home administration of mifepristone |
Primary outcome
Proportion of abortions that are complete without surgical intervention (unit: percent).
Time frame: 15 days
Percentage of women with complete abortion without the need of a surgical intervention.
1 secondary outcome
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).
Time frame: 15 days
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 19 Aug 2014.
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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
Rena Bagirova, MD principal investigator
Antenatal Clinic
Mehriban Huseynova, MD principal investigator
Gynecology Department of the Central Regional Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home administration of 200 mg mifepristone in people with Abortion, First Trimester, run by Gynuity Health Projects at 5 sites in 2 countries.
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 9 inclusion and 8 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 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Azerbaijan, Armenia. 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 abortions that are complete without surgical intervention (unit: percent). (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2014.