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NCT00671060 · ClinicalTrials.gov registry record · Phase 3
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
A Phase 3 study, sponsored by Gynuity Health Projects.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT00671060: Completed Phase 3 study, sponsored by Gynuity Health Projects.
NCT00671060 is a Phase 3 study that has completed, run by Gynuity Health Projects. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00671060, a Phase 3 study, has completed, sponsored by Gynuity Health Projects.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00671060 record still lists
NCT00671060 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Misoprostol is the first listed.
NCT00671060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00671060 about?
NCT00671060 is a clinical study titled "Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy". 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...
What is the current status of trial NCT00671060?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2008-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00671060?
The interventions under investigation include: Misoprostol (DRUG).
Who is sponsoring clinical trial NCT00671060?
This trial is sponsored by Gynuity Health Projects, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00671060's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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