Abortion FailurePhase 4NCT02704481
Non-surgical Alternatives to Treatment of Failed Medical Abortion
A Phase 4 study testing Mifepristone and Misoprostol in people with Abortion Failure, run by Gynuity Health Projects at 14 sites in United States.
Trial summary
The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion. 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 Failure
- What is being tested?
- Mifepristone and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Jun 2016to 16 Jan 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) <= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy
- Agree to comply with study procedures
- Able to consent to study participation
Who cannot join
- Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site
- Are < 18 years old in US and Canadian sites
- Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac
- Are unable to provide contact information for follow-up purposes
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Planned Parenthood of Mid and South Michigan
Ann Arbor, Michigan, 48108
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
Planned Parenthood of Illinois
Chicago, Illinois, 60603
Family Planning Associates Medical Group, Ltd.
Chicago, Illinois, 60661
Planned Parenthood of Northern California
Concord, California, 94520
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80207
Planned Parenthood of the Heartland
Des Moines, Iowa, 50305
Emma Goldman Clinic
Iowa City, Iowa, 52245
Planned Parenthood of Central and Greater Northern New Jersey
Morristown, New Jersey, 07960
Planned Parenthood of the Pacific Southwest
San Diego, California, 92108
Montefiore Family Health Center
The Bronx, New York, 10458
Planned Parenthood of Northern New England
Topsham, Maine, 04086
Presidential Women's Center
West Palm Beach, Florida, 33407
Northland Family Planning Clinic Inc.
Westland, Michigan, 48185
About this study
Official title: Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial
The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.
Read the detailed description
This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies <= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours.
The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.
- Conditions
- Abortion Failure
- Being tested
- Mifepristone, Misoprostol, Placebo mifepristone, Placebo misoprostol
- Keywords
- mifepristone, misoprostol, medical abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called Mifeprex
200mg oral mifepristone
MisoprostolDrug
Also called Cytotec
800mcg buccal misoprostol
Placebo mifepristoneDrug
Matching placebo pill of 200mg mifepristone
Placebo misoprostolDrug
Matching placebo pills of 800mcg misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone-misoprostol | Experimental | Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later. Receives: Drug: Mifepristone; Drug: Misoprostol; Drug: Placebo misoprostol |
| Misoprostol-misoprostol | Experimental | Women randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose. Receives: Drug: Misoprostol; Drug: Placebo mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason.
Measured: One week after taking first study medication
Secondary outcomes (2)
The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
Measured: One week after taking first study medication
The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
Measured: One week after taking first study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start1 Jun 2016
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Why it stopped: Funding mechanism compromised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion FailureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilana Dzuba, MHS, Principal investigator, Gynuity Health ProjectsTara Shochet, PhD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704481
- Sponsor's protocol ID
- 1035
- Status last verified
- Jul 2021
- First submitted
- 2 Mar 2016
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT02704481
- Acronym / sponsor ID
- 1035
- Conditions
- Abortion Failure
- Keywords
- mifepristone, misoprostol, medical abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding mechanism compromised
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 10 Mar 2016 (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 outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.
Detailed description
This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies <= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours.
The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone-misoprostol | Experimental | Drug: Mifepristone, Drug: Misoprostol, Drug: Placebo misoprostolWomen randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later. |
| Misoprostol-misoprostol | Experimental | Drug: Misoprostol, Drug: Placebo mifepristoneWomen randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) <= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy
- Agree to comply with study procedures
- Able to consent to study participation
Key exclusion criteria (4 listed)
- Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site
- Are < 18 years old in US and Canadian sites
- Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac
- Are unable to provide contact information for follow-up purposes
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 |
|---|---|---|
| MifepristoneAlso: Mifeprex200mg oral mifepristone | Drug | Mifepristone-misoprostol |
| MisoprostolAlso: Cytotec800mcg buccal misoprostol | Drug | Mifepristone-misoprostol, Misoprostol-misoprostol |
| Placebo mifepristoneMatching placebo pill of 200mg mifepristone | Drug | Misoprostol-misoprostol |
| Placebo misoprostolMatching placebo pills of 800mcg misoprostol | Drug | Mifepristone-misoprostol |
Primary outcome
The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason.
Time frame: One week after taking first study medication
2 secondary outcomes
The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
Time frame: One week after taking first study medication
The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
Time frame: One week after taking first study medication
Results and safety
The study was stopped early (reason given: Funding mechanism compromised). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Ilana Dzuba, MHS principal investigator
Gynuity Health Projects
Tara Shochet, PhD, MPH principal investigator
Gynuity Health Projects
14 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 Abortion Failure, run by Gynuity Health Projects at 14 sites in United States.
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 3 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 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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 was stopped early (reason given: Funding mechanism compromised). 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?
The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason. (time frame: One week after taking first study medication). 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 26 Jul 2021.