Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2012-03-31, after 2010-09-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-03-31. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: womento determinedetermine whetherpriortreatment
Phrases that lowered it: mildsafety ofagedhypertensionthe efficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 13.5% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 5.8% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 90.3% (raises risk) · Drug's FDA history
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
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 52 (typical: 32)
- Sponsor's past termination rate
- 13.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 30 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 103 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dinoprostone
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 Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor NCT00828711 · started 2009 · scored riskier than 45% 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
- Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) NCT01283022 · started 2011 · scored riskier than 44% of active trials completed
- An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term NCT03067597 · started 2017 · scored riskier than 28% of active trials completed
- A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term NCT03067727 · started 2017 · scored riskier than 28% 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.