Abortion, InducedNCT00784186
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial
A study testing mifepristone+misoprostol and misoprostol in people with Abortion, Induced, run by Gynuity Health Projects at 2 sites in Vietnam.
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 260 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 and misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesVietnam
- Study dates
- Aug 2008to Aug 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
- 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
2 sites in 1 country.
Vietnam2 sites
National Ob-Gyn Hospital
Hanoi
Hung Vuong Hospital
Ho Chi Minh City
About this study
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 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
- Conditions
- Abortion, Induced
- Being tested
- mifepristone+misoprostol, misoprostol, placebo
- 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 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.
misoprostolDrug
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
placeboDrug
placebo resembling mifepristone taken 24 hours before 800 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 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. Receives: Drug: mifepristone+misoprostol; Drug: misoprostol |
| misoprostol | Experimental | 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. Receives: Drug: misoprostol; Drug: placebo |
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 using study drug without recourse to any additional intervention.
Measured: 24 hours
Secondary outcomes (4)
Rate of fetal expulsion: defined as fetal expulsion with study drug alone.
Measured: 24 hours
Induction-to-abortion interval
Measured: Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
Total dose of misoprostol.
Measured: Assessed at time of complete abortion with study drug alone or when total maximum dose given.
Pain experienced by the woman as self-reported.
Measured: Assessed during exit interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionAug 2009
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, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784186
- Sponsor's protocol ID
- 1.3.1
- Status last verified
- Feb 2014
- First submitted
- 30 Oct 2008
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ngoc NTN, Shochet T, Raghavan S, Blum J, Nga NTB, Minh NTH, Phan VQ, Winikoff B. Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):601-608. doi: 10.1097/AOG.0b013e318227214e.
PubMed 21860289
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. 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
- NCT00784186
- Acronym / sponsor ID
- 1.3.1
- Conditions
- Abortion, Induced
- Keywords
- Pregnancy termination, abortion, medical abortion, 2nd trimester, mifepristone, misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 3 Nov 2008 (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 260 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+misoprostol, Drug: misoprostol200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
| misoprostol | Experimental | Drug: misoprostol, Drug: placebo800 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 (7 listed)
- 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
- 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
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 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses. | Drug | mifepristone+misoprostol |
| misoprostolplacebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. | Drug | mifepristone+misoprostol, misoprostol |
| placeboplacebo resembling mifepristone taken 24 hours before 800 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 using study drug without recourse to any additional intervention.
Time frame: 24 hours
4 secondary outcomes
Rate of fetal expulsion: defined as fetal expulsion with study drug alone.
Time frame: 24 hours
Induction-to-abortion interval
Time frame: Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
Total dose of misoprostol.
Time frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given.
Pain experienced by the woman as self-reported.
Time frame: Assessed during 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 20 Feb 2014.
- Derived from this study: PubMed 21860289Ngoc NTN, Shochet T, Raghavan S, Blum J, Nga NTB, Minh NTH, Phan VQ, Winikoff B. Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):601-608. doi: 10.1097/AOG.0b013e318227214e.
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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 principal investigator
Gynuity Health Projects
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mifepristone+misoprostol and misoprostol in people with Abortion, Induced, run by Gynuity Health Projects at 2 sites in Vietnam.
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 7 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: finished, as of the sponsor's last update on 20 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 2 sites in 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?
Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. (time frame: 24 hours). 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 NCT00784186, 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 20 Feb 2014.