Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (60 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-11-11, after 2018-11-05 start.
Reason given by the sponsor: “enrollment”
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 2021-11-11. 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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Sponsor's past termination rate: 30.9% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: intrauterinewomenpatientdiabetespregnancy
Phrases that lowered it: asthmachallengeinhaledto evaluateconsent form -
Drug's FAERS reports marked serious: 52.3% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 51 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 2/3 (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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Blinding: single (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 165 (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (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
- academic or other
- Sponsor's past trials
- 165 (typical: 32)
- Sponsor's past termination rate
- 30.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 51 (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
- 42526 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5746 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- acetylcysteine
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
- Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio) NCT00724594 · started 2008 · scored riskier than 79% of active trials completed
- Effect of L-arginine and Glutamine on Preterm NCT01263041 · started 2011 · scored riskier than 14% of active trials completed
- Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial NCT01222247 · started 2010 · scored riskier than 27% of active trials completed
- Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease NCT02395783 · started 2015 · scored riskier than 94% of active trials terminated
- Phase I Study of Nicotinamide for Early Onset Preeclampsia NCT02213094 · started 2014 · scored riskier than 45% 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.