Fetal DeathPhase 3NCT02633761
Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
A Phase 3 study testing Mifepristone and Misoprostol 200mcg in people with Fetal Death, run by Gynuity Health Projects at 3 sites in 2 countries.
Trial summary
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Death
- What is being tested?
- Mifepristone and Misoprostol 200mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Apr 2015to 30 Dec 2018
- 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 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound
- Have no contraindications to study procedure, 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
- Allergies or other contraindications to the use of mifepristone or misoprostol;
- Placental abruption with active hemorrhage,
- Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus;
- Presentation in active labor (moderate to severe contractions every 10 minutes or less);
- Transmural uterine scars;
- Four or more previous deliveries.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Mexico2 sites
Hospital General "Enrique Cabrera"
Mexico City
National Institute of Perinatology (INPer)
Mexico City
About this study
Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.
Read the detailed description
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening 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:
- STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;
- STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
- Conditions
- Fetal Death
- Being tested
- Mifepristone, Placebo, Misoprostol 200mcg
- Keywords
- Fetal death, mifepristone, misoprostol
- Medical subject headings
- Fetal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
PlaceboDrug
placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
Misoprostol 200mcgDrug
Buccal misoprostol 200mcg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours Receives: Drug: Mifepristone; Drug: Misoprostol 200mcg |
| Group 2 | Placebo comparator | placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours. Receives: Drug: Placebo; Drug: Misoprostol 200mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete uterine evacuation of the fetus and placenta without surgical intervention
Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start1 Apr 2015
- Primary completion30 Dec 2018
- Study completion30 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 Fetal DeathStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT02633761
- Sponsor's protocol ID
- 1019
- Status last verified
- Jan 2019
- First submitted
- 8 Dec 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT02633761
- Acronym / sponsor ID
- 1019
- Conditions
- Fetal Death
- Keywords
- Fetal death, mifepristone, misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 17 Dec 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 primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.
Detailed description
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening 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:
- STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;
- STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
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 |
|---|---|---|
| Group 1 | Active comparator | Drug: Mifepristone, Drug: Misoprostol 200mcg200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours |
| Group 2 | Placebo comparator | Drug: Placebo, Drug: Misoprostol 200mcgplacebo followed in 24 hours by 200mcg buccal misoprostol given every three hours. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound
- Have no contraindications to study procedure, 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.
Key exclusion criteria (6 listed)
- Allergies or other contraindications to the use of mifepristone or misoprostol;
- Placental abruption with active hemorrhage,
- Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus;
- Presentation in active labor (moderate to severe contractions every 10 minutes or less);
- Transmural uterine scars;
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 |
|---|---|---|
| Mifepristone200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours. | Drug | Group 1 |
| Placeboplacebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours. | Drug | Group 2 |
| Misoprostol 200mcgBuccal misoprostol 200mcg | Drug | Group 1, Group 2 |
Primary outcome
Complete uterine evacuation of the fetus and placenta without surgical intervention
Time frame: 48 hours
Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention
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 11 Feb 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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone and Misoprostol 200mcg in people with Fetal Death, run by Gynuity Health Projects at 3 sites in 2 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 4 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 11 Feb 2019. 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 Mexico, 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. 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 (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?
Complete uterine evacuation of the fetus and placenta without surgical intervention (time frame: 48 hours). 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 11 Feb 2019.