Missed AbortionPhase 4NCT02342002
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
A Phase 4 study testing Mifepristone and Misoprostol in people with Missed Abortion and Pregnancy, run by Gynuity Health Projects at 4 sites in 4 countries.
Trial summary
The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion, Pregnancy
- 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
- 416 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 2015to 31 Dec 2018
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ultrasound examination demonstrating:
- Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
- Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
- If fetus exists, fetal size less than 12 weeks+6 days
- Closed cervical os
- Eligible to consent for research according to local regulations
Who cannot join
- Active bleeding at enrollment and/or history of bleeding within the prior week
- Allergies or other contraindications to the use of mifepristone or misoprostol
- Suspected ectopic pregnancy
- History of trophoblastic disease
- Coagulation disorder and/or currently taking anticoagulants
- Any serious medical condition
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.
Read the detailed description
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.
- Conditions
- Missed Abortion, Pregnancy
- Being tested
- Mifepristone, Misoprostol
- Keywords
- mifepristone, misoprostol, obstetrics, reproductive health, pregnancy, abortion, missed abortion
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Mifepristone for treatment of missed abortion
MisoprostolDrug
Misoprostol for treatment of missed abortion
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone-misoprostol regimen | Experimental | After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually. Receives: Drug: Mifepristone; Drug: Misoprostol |
| Misoprostol alone regimen | Placebo comparator | After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful evacuation of the uterus
uterine evacuation without the need for uterine aspiration or other surgery
Measured: 1 week after treatment
Secondary outcomes (4)
Rate of successful evacuation without any additional intervention
uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
Measured: 1 week after treatment
Excessive bleeding or a complication for which a woman received treatment
Measured: 30 days after treatment
Induction expulsion interval after misoprostol administration
time interval between misoprostol administration and the expulsion
Measured: one week follow-up
Acceptability of assigned method to women
Measured: one week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillary Bracken, PhD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342002
- Sponsor's protocol ID
- 1015
- Status last verified
- Nov 2018
- First submitted
- 9 Jan 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT02342002
- Acronym / sponsor ID
- 1015
- Conditions
- Missed Abortion, Pregnancy
- Keywords
- mifepristone, misoprostol, obstetrics, reproductive health, pregnancy, abortion, missed abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jan 2015 (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 purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.
Detailed description
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.
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 regimen | Experimental | Drug: Mifepristone, Drug: MisoprostolAfter a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually. |
| Misoprostol alone regimen | Placebo comparator | Drug: MisoprostolAfter a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ultrasound examination demonstrating:
- If fetus exists, fetal size less than 12 weeks+6 days
- Closed cervical os
- Eligible to consent for research according to local regulations
Key exclusion criteria (6 listed)
- Active bleeding at enrollment and/or history of bleeding within the prior week
- Allergies or other contraindications to the use of mifepristone or misoprostol
- Suspected ectopic pregnancy
- History of trophoblastic disease
- Coagulation disorder and/or currently taking anticoagulants
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 |
|---|---|---|
| MifepristoneMifepristone for treatment of missed abortion | Drug | Mifepristone-misoprostol regimen |
| MisoprostolMisoprostol for treatment of missed abortion | Drug | Mifepristone-misoprostol regimen, Misoprostol alone regimen |
Primary outcome
Rate of successful evacuation of the uterus
Time frame: 1 week after treatment
uterine evacuation without the need for uterine aspiration or other surgery
4 secondary outcomes
Rate of successful evacuation without any additional intervention
Time frame: 1 week after treatment
Excessive bleeding or a complication for which a woman received treatment
Time frame: 30 days after treatment
Induction expulsion interval after misoprostol administration
Time frame: one week follow-up
Acceptability of assigned method to women
Time frame: one week follow-up
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Hillary Bracken, PhD principal investigator
Gynuity Health Projects
4 sites in 4 countries: 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 Missed Abortion and Pregnancy, run by Gynuity Health Projects at 4 sites in 4 countries.
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 6 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina, Gabon, Mexico, Pakistan. 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 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: lack of funding). 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 evacuation of the uterus (time frame: 1 week after treatment). 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 15 Jan 2019.