Intrauterine Fetal DemisePhase 3NCT00671060
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
A Phase 3 study testing Misoprostol in people with Intrauterine Fetal Demise, run by Gynuity Health Projects at 5 sites in 2 countries.
Trial summary
The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intrauterine Fetal Demise
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2008to Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women presents with spontaneous fetal death
- Gestational age of fetus between 14-28 weeks
Who cannot join
- Transmural uterine scar;
- Allergies or other contraindications to use of misoprostol;
- Placental abruption with active hemorrhage;
- Complete placenta previa;
- Extreme uterine structural anomalies;
- Or other contraindications to vaginal delivery of the fetus;
- Presentation in active labor (moderate to severe contractions every 10 minutes); or
- Four or more previous deliveries
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Illinois at Chicago
Chicago, Illinois, 60622
Christiana Care Health System
Newark, Delaware, 19718
Stanford University
Palo Alto, California, 94305
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy, Inclusive, Not Accompanied by Complete Expulsion of the Contents of the Uterus
The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D\&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.
- Conditions
- Intrauterine Fetal Demise
- Being tested
- Misoprostol
- Keywords
- intrauterine fetal death, misoprostol
- Medical subject headings
- Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.
MisoprostolDrug
100 mcg buccal misoprostol administered every 6 hours for upto 48 hours
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose. Receives: Drug: Misoprostol |
| 1 | Placebo comparator | Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Expulsion of Fetus and Placenta Within 48 Hours
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 posted2 May 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intrauterine Fetal DemiseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Albert Einstein College of Medicine, University of Florida, Hung Vuong Hospital, Boston Medical Center, Christiana Care Health Services, University of Illinois Chicago
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671060
- Sponsor's protocol ID
- 3.3
- Other IDs
- 1R01FD003107-01A1
- Status last verified
- May 2013
- First submitted
- 29 Apr 2008
- Last updated
- 8 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy, Inclusive, Not Accompanied by Complete Expulsion of the Contents of the Uterus
- ClinicalTrials.gov ID
- NCT00671060
- Acronym / sponsor ID
- 3.3
- Conditions
- Intrauterine Fetal Demise
- Keywords
- intrauterine fetal death, misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Stanford University, Albert Einstein College of Medicine, University of Florida, Hung Vuong Hospital, Boston Medical Center, Christiana Care Health Services, University of Illinois Chicago
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Posted 6 May 2013
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 test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D\&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.
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 |
|---|---|---|
| 2 | Active comparator | Drug: MisoprostolWomen in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose. |
| 1 | Placebo comparator | Drug: MisoprostolWomen in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women presents with spontaneous fetal death
- Gestational age of fetus between 14-28 weeks
Key exclusion criteria (8 listed)
- Transmural uterine scar;
- Allergies or other contraindications to use of misoprostol;
- Placental abruption with active hemorrhage;
- Complete placenta previa;
- Extreme uterine structural anomalies;
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 |
|---|---|---|
| Misoprostol200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered. | Drug | 2 |
| Misoprostol100 mcg buccal misoprostol administered every 6 hours for upto 48 hours | Drug | 1 |
Primary outcome
Successful Expulsion of Fetus and Placenta Within 48 Hours
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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, MD, MPH principal investigator
Gynuity Health Projects
5 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 Misoprostol in people with Intrauterine Fetal Demise, run by Gynuity Health Projects at 5 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 2 inclusion and 8 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 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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?
Yes. Results are posted in the registry (first posted 6 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Expulsion of Fetus and Placenta Within 48 Hours (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 8 May 2013.