Abortion, First TrimesterNCT02398838
Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia
A study testing Home administration of 200 mg mifepristone and Home or clinic administration of 400 mcg buccal misoprostol in people with Abortion, First Trimester, run by Gynuity Health Projects at 4 sites in Georgia.
Trial summary
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable 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 and Home or clinic administration of 400 mcg buccal misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 4 sitesGeorgia
- Study dates
- Dec 2009to Apr 2012
- 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
- At least 18 years old
- In 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
- 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
4 sites in 1 country.
Georgia4 sites
Batumi Maternity House
Batumi, Adjara
Bolnisi Maternity House
Bolnisi, Kvemo Kartli
A. Kambarashvili Clinic
Telavi, Kakheti
Zestafoni Maternity House
Zestaponi, Imereti
About this study
Official title: Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.
Read the detailed description
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.
- Conditions
- Abortion, First Trimester
- Being tested
- Home administration of 200 mg mifepristone, Home or clinic administration of 400 mcg buccal misoprostol
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
Also called Penkrofton
Home administration of 200 mg mifepristone.
Home or clinic administration of 400 mcg buccal misoprostolDrug
Home or clinic administration of 400 mcg buccal misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Home administration of mifepristone | Experimental | Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. Receives: Drug: Home administration of 200 mg mifepristone; Drug: Home or clinic administration of 400 mcg buccal misoprostol |
| Clinic administration of mifepristone | Active comparator | Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. Receives: Drug: Home or clinic administration of 400 mcg buccal misoprostol |
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 posted26 Mar 2015 (estimated)
- Study startDec 2009
- Primary completionApr 2012
- Study completionApr 2012
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
- 622 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
- NCT02398838
- Sponsor's protocol ID
- 1.2.4.5
- Status last verified
- Apr 2015
- First submitted
- 12 Sep 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation
- ClinicalTrials.gov ID
- NCT02398838
- Acronym / sponsor ID
- 1.2.4.5
- Conditions
- Abortion, First Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Mar 2015 (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 the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.
Detailed description
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.
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 mifepristone, Drug: Home or clinic administration of 400 mcg buccal misoprostolHome administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. |
| Clinic administration of mifepristone | Active comparator | Drug: Home or clinic administration of 400 mcg buccal misoprostolClinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- At least 18 years old
- In 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 mifepristoneAlso: PenkroftonHome administration of 200 mg mifepristone. | Drug | Home administration of mifepristone |
| Home or clinic administration of 400 mcg buccal misoprostolHome or clinic administration of 400 mcg buccal misoprostol | Drug | Clinic administration of mifepristone, 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 6 Apr 2015.
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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
4 sites in 1 country: 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 and Home or clinic administration of 400 mcg buccal misoprostol in people with Abortion, First Trimester, run by Gynuity Health Projects at 4 sites in Georgia.
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 8 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 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia. 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 6 Apr 2015.