Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (84 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 2022-08-31, after 2010-10-31 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 2022-08-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartpatientrandomizationfailurecardiac
Phrases that lowered it: periodvaginaltrialto evaluatecorticosteroids -
Sponsor's past termination rate: 33.3% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 15.1% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Collaborators: 2 (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Minimum age: not given (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 91.7% (raises risk) · Drug's FDA history
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Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- not given (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
- 6 (typical: 32)
- Sponsor's past termination rate
- 33.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 1328 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 238 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, urogenital
- Drugs matched to FDA substances
- betamethasone
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
- Effects of ACS in Twin With LPB: Study Protocol for a RCT NCT03547791 · started 2018 · scored riskier than 14% of active trials completed
- Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth NCT04494529 · started 2021 · scored riskier than 14% of active trials completed
- Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone. NCT06569251 · started 2024 · scored riskier than 16% of active trials completed
- A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix NCT02518594 · started 2015 · scored riskier than 81% of active trials completed
- Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes NCT02469519 · started 2016 · scored riskier than 25% 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.