Abortion, First TrimesterNCT00386282
Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol
A study testing mifepristone-misoprostol treatment in people with Abortion, First Trimester, run by Gynuity Health Projects at 11 sites in 4 countries.
Trial summary
This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. 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
- Abortion, First Trimester
- What is being tested?
- mifepristone-misoprostol treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Sep 2006to Mar 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestation up to 63 days
- General good health
- Willingness to provide contact information for follow-up
- Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination
Who cannot join
- Ectopic pregnancy
- Intrauterine device (IUD) in place
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Mexico4 sites
C.S. Beatriz Velasco Aleman
Mexico City, Federal District
C.S. Santa Catarina
Mexico City, Federal District
H.G. Enrique Cabrera
Mexico City, Federal District
H.M.I Inguaran
Mexico City, Federal District
Armenia3 sites
Center for Family Planning and Sexual Health
Yerevan
Institute of Perinatology, Obstetrics and Gynecology
Yerevan
State Medical University
Yerevan
Azerbaijan2 sites
Family Planning Center
Baku
Scientific Research Institute of Obstetrics and Gynecology
Baku
Puerto Rico2 sites
Clinica de Planificacion Familiar
Lomas Verdes, Bayamon, 00956
Woman's Metropolitan Center
San Juan, 00921
About this study
Official title: Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation
This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen 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, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.
- Conditions
- Abortion, First Trimester
- Being tested
- mifepristone-misoprostol treatment
- Keywords
- Mifepristone, Misoprostol, Buccal administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristone-misoprostol treatmentDrug
Also called medical abortion
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.
| Study group | Role | What they receive |
|---|---|---|
| mifepristone-misoprostol treatment | Other | 200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone Receives: Drug: mifepristone-misoprostol treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
Measured: 15 days
Secondary outcomes (1)
acceptability
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 posted11 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2011
- Study completionMar 2011
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector Diaz Martinez, MD, Principal investigator, Clinica de Planificacion FamiliarAngela Arredondo, MD, Principal investigator, Woman's Metropolitan CenterBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsGulnara Rzaeva, MD, Principal investigator, Scientific Research Institute of Obstetrics & GynecologyBesti Muradova, MD, Principal investigator, Family Planning CenterSusanna Fildjyan, MD, Principal investigator, Institute of Perinatology, Obstetrics and GynecologyArmine Harutyunyan, MD, Principal investigator, Center for Family Planning and Sexual HealthAnna Aghajanyan, MD, Principal investigator, State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386282
- Sponsor's protocol ID
- 1.1.4
- Status last verified
- Jul 2014
- First submitted
- 9 Oct 2006
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pena M, Dzuba IG, Smith PS, Mendoza LJ, Bousieguez M, Martinez ML, Polanco RR, Villalon AE, Winikoff B. Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City. Int J Gynaecol Obstet. 2014 Oct;127(1):82-5. doi: 10.1016/j.ijgo.2014.04.012. Epub 2014 Jun 4.
PubMed 24957534
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation
- ClinicalTrials.gov ID
- NCT00386282
- Acronym / sponsor ID
- 1.1.4
- Conditions
- Abortion, First Trimester
- Keywords
- Mifepristone, Misoprostol, Buccal administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Oct 2006 (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 introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen 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, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mifepristone-misoprostol treatment | Other | Drug: mifepristone-misoprostol treatment200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gestation up to 63 days
- General good health
- Willingness to provide contact information for follow-up
- Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination
Key exclusion criteria (2 listed)
- Ectopic pregnancy
- Intrauterine device (IUD) in place
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-misoprostol treatmentAlso: medical abortion200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone. | Drug | mifepristone-misoprostol treatment |
Primary outcome
efficacy
Time frame: 15 days
1 secondary outcome
acceptability
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 30 Jul 2014.
- Derived from this study: PubMed 24957534Pena M, Dzuba IG, Smith PS, Mendoza LJ, Bousieguez M, Martinez ML, Polanco RR, Villalon AE, Winikoff B. Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City. Int J Gynaecol Obstet. 2014 Oct;127(1):82-5. doi: 10.1016/j.ijgo.2014.04.012. Epub 2014 Jun 4.
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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.
Hector Diaz Martinez, MD principal investigator
Clinica de Planificacion Familiar
Angela Arredondo, MD principal investigator
Woman's Metropolitan Center
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mifepristone-misoprostol treatment in people with Abortion, First Trimester, run by Gynuity Health Projects at 11 sites in 4 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 4 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 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Mexico, Armenia, Azerbaijan, Puerto Rico. 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?
efficacy (time frame: 15 days). 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 NCT00386282, 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 30 Jul 2014.