Abortion, InducedPhase 3NCT00957346
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)
A Phase 3 study testing Mifepristone+misoprostol in people with Abortion, Induced, run by Gynuity Health Projects at 1 site in Puerto Rico.
Trial summary
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- Mifepristone+misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Feb 2011to Jan 2012
- Phase
- Phase 3
- 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
- Meet legal criteria to obtain abortion
- Present with closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- Have no contraindications to study procedures, according to provider
- Be able to consent to procedure, either by reading consent document or by having consent document read to her
- Be willing to follow study procedures
Who cannot join
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery, including placenta previa
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico, University District Hospital Medical Science Campus
San Juan, 00936-5067
About this study
Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
- Conditions
- Abortion, Induced
- Being tested
- Mifepristone+misoprostol, Placebo+Misoprostol
- Keywords
- Pregnancy termination, abortion, medical abortion, 2nd trimester, mifepristone, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone+misoprostolDrug
single dose of 200 mg mifepristone followed 24 hours later by 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.
Placebo+MisoprostolDrug
placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone + Misoprostol | Experimental | 200 mg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. Receives: Drug: Mifepristone+misoprostol |
| Misoprostol | Placebo comparator | Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses Receives: Drug: Placebo+Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
Measured: every 3 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours.
Measured: 48 hours
Secondary outcomes (5)
Provision of additional interventions to manage excessive blood loss.
Measured: Within 30 days of mifepristone administration.
Total dose of misoprostol.
Measured: Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration.
Any heavy bleeding, uterine rupture, or infection requiring additional treatment
Measured: Within 30 days of mifepristone administration.
Pain experienced by the woman
Measured: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Women's acceptability of the assigned method
Measured: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startFeb 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, InducedStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Beverly Winkoff, M.D., M.P.H, Principal investigator, Gynuity Health ProjectsYari Vale-Moreno, M.D., Principal investigator, University of Puerto Rico Department of Obstetrics and GynecologyMelanie Pena, MPH, MA, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957346
- Sponsor's protocol ID
- 1.3.2
- Status last verified
- Nov 2011
- First submitted
- 5 Aug 2009
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT00957346
- Acronym / sponsor ID
- 1.3.2
- Conditions
- Abortion, Induced
- Keywords
- Pregnancy termination, abortion, medical abortion, 2nd trimester, mifepristone, misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- University of Puerto Rico
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 12 Aug 2009 (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.
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone + Misoprostol | Experimental | Drug: Mifepristone+misoprostol200 mg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
| Misoprostol | Placebo comparator | Drug: Placebo+MisoprostolPlacebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Meet legal criteria to obtain abortion
- Present with closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- Have no contraindications to study procedures, according to provider
- Be able to consent to procedure, either by reading consent document or by having consent document read to her
Key exclusion criteria (4 listed)
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery, including placenta previa
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
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+misoprostolsingle dose of 200 mg mifepristone followed 24 hours later by 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses. | Drug | Mifepristone + Misoprostol |
| Placebo+Misoprostolplacebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. | Drug | Misoprostol |
Primary outcome
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
Time frame: every 3 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours.
Time frame: 48 hours
5 secondary outcomes
Provision of additional interventions to manage excessive blood loss.
Time frame: Within 30 days of mifepristone administration.
Total dose of misoprostol.
Time frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration.
Any heavy bleeding, uterine rupture, or infection requiring additional treatment
Time frame: Within 30 days of mifepristone administration.
Pain experienced by the woman
Time frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Women's acceptability of the assigned method
Time frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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 Winkoff, M.D., M.P.H principal investigator
Gynuity Health Projects
Yari Vale-Moreno, M.D. principal investigator
University of Puerto Rico Department of Obstetrics and Gynecology
Melanie Pena, MPH, MA study director
Gynuity Health Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone+misoprostol in people with Abortion, Induced, run by Gynuity Health Projects at 1 site in Puerto Rico.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Nov 2011. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention. (time frame: every 3 hours). The study lists 2 primary outcomes in all. 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 8 Nov 2011.