Complete Uterine Evacuation After Use of Study DrugsPhase 4NCT01768299
Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)
A Phase 4 study testing Mifepristone and Misoprostol in people with Complete Uterine Evacuation After Use of Study Drugs, run by Gynuity Health Projects at 3 sites in Vietnam.
Trial summary
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Uterine Evacuation After Use of Study Drugs
- What is being tested?
- Mifepristone and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 3 sitesVietnam
- Study dates
- Feb 2013to May 2014
- Phase
- Phase 4
- 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
- Closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- No contraindications to medical abortion and study procedures, according to provider
- Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
- Willing to follow study procedures
Who cannot join
- Known previous transmural uterine incision
- > 5 parity
- Signs and symptoms of infection
- 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
3 sites in 1 country.
Vietnam3 sites
National Ob-Gyn Hospital
Hanoi
Binh duong Obstetrics and Newborn Hospital
Ho Chi Minh City, Binh Duong Province
Hung Vuong Hospital
Ho Chi Minh City
About this study
Official title: Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
- Being tested
- Mifepristone, Misoprostol
- Keywords
- abortion, medical abortion, mifepristone, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
MisoprostolDrug
200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone at home 24 hours before miso dosing starts | Experimental | All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.
Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. Receives: Drug: Mifepristone |
| Mifepristone and first dose of misoprostol simultaneously. | Experimental | Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.
Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
Measured: Within 1 week
Secondary outcomes (6)
Induction to abortion interval
Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.
Measured: Within 1 week
Women's acceptability of the assigned method.
Measured: Within 1 week
Rate of fetal expulsion
Defined as fetal expulsion with study drug alone.
Measured: Within 1 week
Provision of additional interventions
For example: Uterine massage, Manual removal, Sponge forceps, D\&C or D\&E, Repeat medical abortion drugs
Measured: Within 1 week
Time interval from the mifepristone dose to abortion
Defined as length of time from initiation of mifepristone to complete abortion achieved.
Measured: Within 1 week
Total dose of misoprostol administered
Measured: Within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Complete Uterine Evacuation After Use of Study DrugsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Blum, MPH, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsDina Abbas, MPH, Principal investigator, Gynuity Health ProjectsNguyen thi Ngoc, MD, Principal investigator, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768299
- Sponsor's protocol ID
- 1008
- Status last verified
- May 2014
- First submitted
- 11 Jan 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Abbas DF, Blum J, Ngoc NT, Nga NT, Chi HT, Martin R, Winikoff B. Simultaneous Administration Compared With a 24-Hour Mifepristone-Misoprostol Interval in Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1077-1083. doi: 10.1097/AOG.0000000000001688.
PubMed 27741182
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT01768299
- Acronym / sponsor ID
- 1008
- Keywords
- abortion, medical abortion, mifepristone, misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Jan 2013 (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.
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone at home 24 hours before miso dosing starts | Experimental | Drug: MifepristoneAll women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. |
| Mifepristone and first dose of misoprostol simultaneously. | Experimental | Drug: MisoprostolWill receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- No contraindications to medical abortion and study procedures, according to provider
- Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
- Willing to follow study procedures
Key exclusion criteria (5 listed)
- Known previous transmural uterine incision
- > 5 parity
- Signs and symptoms of infection
- 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 |
|---|---|---|
| Mifepristone200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol | Drug | Mifepristone at home 24 hours before miso dosing starts |
| Misoprostol200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol | Drug | Mifepristone and first dose of misoprostol simultaneously. |
Primary outcome
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
Time frame: Within 1 week
Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
6 secondary outcomes
Induction to abortion interval
Time frame: Within 1 week
Women's acceptability of the assigned method.
Time frame: Within 1 week
Rate of fetal expulsion
Time frame: Within 1 week
Provision of additional interventions
Time frame: Within 1 week
Time interval from the mifepristone dose to abortion
Time frame: Within 1 week
Total dose of misoprostol administered
Time frame: Within 1 week
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 14 May 2014.
- Derived from this study: PubMed 27741182Abbas DF, Blum J, Ngoc NT, Nga NT, Chi HT, Martin R, Winikoff B. Simultaneous Administration Compared With a 24-Hour Mifepristone-Misoprostol Interval in Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1077-1083. doi: 10.1097/AOG.0000000000001688.
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.
Jennifer Blum, MPH principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Dina Abbas, MPH principal investigator
Gynuity Health Projects
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone and Misoprostol in people with Complete Uterine Evacuation After Use of Study Drugs, run by Gynuity Health Projects at 3 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 5 inclusion and 5 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. (time frame: Within 1 week). 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 NCT01768299, 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 14 May 2014.