Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (169 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-12-30, after 2015-04-01 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-12-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 2.1% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 56.5% (lowers risk) · Drug's FDA history
-
Phase: 3 (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 6.1% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Maximum age: 64 (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: placebo controlleddeathactiverandomized placebohemorrhage
Phrases that lowered it: the efficacyaccordingtrialcompare theto compare -
Responsible party: sponsor (raises risk) · Design
-
Sponsor's past trials: 48 (lowers risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 64 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 48 (typical: 32)
- Sponsor's past termination rate
- 2.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 10225 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1677 (typical: 412.5)
- Drug's FAERS reports marked serious
- 56.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- mifepristone, misoprostol
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy NCT00671060 · started 2008 · scored riskier than 13% of active trials completed
- Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP) NCT00957346 · started 2011 · scored riskier than 8% of active trials terminated
- Comparative Effectiveness of Pregnancy Failure Management Regimens NCT02012491 · started 2014 · scored riskier than 73% of active trials completed
- Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages NCT05304273 · started 2022 · scored riskier than 32% of active trials completed
- Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor NCT01428037 · started 2012 · scored riskier than 8% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.