Induced AbortionNCT01173003
Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia
A study testing Mifepristone, misoprostol in people with Induced Abortion, run by Gynuity Health Projects at 1 site in Tunisia.
Trial summary
This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion
- What is being tested?
- Mifepristone, misoprostol
- How many people
- 688 participants
- Where
- 1 siteTunisia
- Study dates
- Jun 2009to Dec 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women presenting for medical abortion who consent to participate
- Possibility of final gestational age of less than or equal to 63 days
- General good health
- Willing to provide contact information 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
1 site in 1 country.
Tunisia1 site
Centres (14) de Planification Familiale de L'ONFP
Tunis, Various
About this study
Official title: An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP
This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.
The goal of this study is to provide answers to the following four questions:
- What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Are women satisfied with counseling and services received in new centers offering medical abortion?
- Conditions
- Induced Abortion
- Being tested
- Mifepristone, misoprostol
- Keywords
- Medical abortion, mifepristone, misoprostol, Tunisia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone, misoprostolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Measured: 2 weeks after mifepristone administration
Secondary outcomes (2)
Side effects
Measured: 48 hours
Acceptability for women
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Formation et de la Recherche, Tunisia
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Study chair, Gynuity Health ProjectsRasha Dabash, MPH, Study director, Gynuity Health ProjectsSelma Hajri, MD, Principal investigator, Reproductive Health ConsultantMongia Ben Attia, MD, Principal investigator, Office Nationale de la Famille et de la PopulationN Gueddana, MD, Study chair, ONFPFatma Temimi, MD, Principal investigator, ONFPE Hassairi, Principal investigator, ONFP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173003
- Sponsor's protocol ID
- 1.1.7
- Status last verified
- Feb 2014
- First submitted
- 28 Jul 2010
- Last updated
- 19 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP
- ClinicalTrials.gov ID
- NCT01173003
- Acronym / sponsor ID
- 1.1.7
- Conditions
- Induced Abortion
- Keywords
- Medical abortion, mifepristone, misoprostol, Tunisia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Centre de Formation et de la Recherche, Tunisia
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jul 2010 (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 open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.
The goal of this study is to provide answers to the following four questions:
- What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Are women satisfied with counseling and services received in new centers offering medical abortion?
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women presenting for medical abortion who consent to participate
- Possibility of final gestational age of less than or equal to 63 days
- General good health
- Willing to provide contact information 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, misoprostol | Drug | – |
Primary outcome
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Time frame: 2 weeks after mifepristone administration
2 secondary outcomes
Side effects
Time frame: 48 hours
Acceptability for women
Time frame: 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 19 Feb 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 study chair
Gynuity Health Projects
Rasha Dabash, MPH study director
Gynuity Health Projects
Selma Hajri, MD principal investigator
Reproductive Health Consultant
1 site in 1 country: 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 1 site in Tunisia.
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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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 incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. (time frame: 2 weeks after mifepristone administration). 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 Feb 2014.