Induced AbortionNCT00482209
Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation
A study testing Mifepristone, misoprostol in people with Induced Abortion, run by Gynuity Health Projects at 4 sites in 2 countries.
Trial summary
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP. 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
- Induced Abortion
- What is being tested?
- Mifepristone, misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2007to Oct 2009
- 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 or over presenting for abortion services who consent to participate
- good general health
- assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
- Have ready access to a telephone and emergency transportation;
- Be willing to provide an address and/or telephone number for purposes of follow-up
Who cannot join
- Conditions which contraindicate the use of mifepristone or misoprostol
- Women presenting for medical abortion who do not consent to participate
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Georgia3 sites
Maternity House #2
Tbilisi
Maternity House #4
Tbilisi
Zhordania Institute of Human Reproduction
Tbilisi
About this study
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.
Read the detailed description
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with buccal use tolerable for women?
- Is buccal administration of misoprostol acceptable to women?
- When given a choice, do women prefer to take misoprostol at home or in the clinic?
- Conditions
- Induced Abortion
- Being tested
- Mifepristone, misoprostol
- Keywords
- mifepristone, misoprostol, medical abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone, misoprostolDrug
200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
mifepristone, misoprostolDrug
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 200mg mifepristone followed by 400mcg misoprostol Receives: Drug: Mifepristone, misoprostol |
| 2 | Active comparator | 200mg mifepristone followed by 800mcg misoprostol Receives: Drug: mifepristone, misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).
Measured: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit
Secondary outcomes (1)
Side-effects, acceptability for women
Measured: side effects and acceptability recorded at exit interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsErica Chong, MPH, Study director, Gynuity Health ProjectsTamuna Tsereteli, MD, MSc, PhD, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482209
- Sponsor's protocol ID
- 1.1.6
- Status last verified
- Oct 2009
- First submitted
- 4 Jun 2007
- Last updated
- 12 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation
- ClinicalTrials.gov ID
- NCT00482209
- Acronym / sponsor ID
- 1.1.6
- Conditions
- Induced Abortion
- Keywords
- mifepristone, misoprostol, medical abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Jun 2007 (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 double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.
Detailed description
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with buccal use tolerable for women?
- Is buccal administration of misoprostol acceptable to women?
- When given a choice, do women prefer to take misoprostol at home or in the clinic?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Mifepristone, misoprostol200mg mifepristone followed by 400mcg misoprostol |
| 2 | Active comparator | Drug: mifepristone, misoprostol200mg mifepristone followed by 800mcg misoprostol |
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 or over presenting for abortion services who consent to participate
- good general health
- assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
- Have ready access to a telephone and emergency transportation;
- Be willing to provide an address and/or telephone number for purposes of follow-up
Key exclusion criteria (2 listed)
- Conditions which contraindicate the use of mifepristone or misoprostol
- Women presenting for medical abortion who do not consent to participate
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 |
|---|---|---|
| Mifepristone, misoprostol200mg mifepristone followed by 400mcg misoprostol 36-48 hours later | Drug | 1 |
| mifepristone, misoprostol200mg mifepristone followed by 800mcg misoprostol 36-48 hours later | Drug | 2 |
Primary outcome
Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).
Time frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit
1 secondary outcome
Side-effects, acceptability for women
Time frame: side effects and acceptability recorded at exit interview
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 12 Oct 2009.
- Related InfoLink provided by the sponsor.
Related trials for Induced Abortion
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
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
Erica Chong, MPH study director
Gynuity Health Projects
Tamuna Tsereteli, MD, MSc, PhD study director
Gynuity Health Projects
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone, misoprostol in people with Induced Abortion, run by Gynuity Health Projects at 4 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 5 inclusion and 2 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 12 Oct 2009. 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, Vietnam. 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?
Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22). (time frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit). 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 12 Oct 2009.