Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section
Model scores of the 29,894 trials active now.
Model score 17% 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 10% of the time (273 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-05-20, after 2016-07-31 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 2021-05-20. 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: painhoursopioid48care
Phrases that lowered it: dexamethasonedoseescalationcombinationgeneral -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 93 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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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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Design: parallel (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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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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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 240 (lowers risk) · Sponsor's track record
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Drugs with FDA adverse-event history: 5 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 31025 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 140653 (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports marked serious: 86.4% (raises risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports with a death: 23.8% (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
- 2/3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 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
- 240 (typical: 32)
- Sponsor's past termination rate
- 12.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 93 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 140653 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 31025 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- bupivacaine, dexamethasone, dobesilate, morphine, ropivacaine
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
- Dexamethasone Intravenous Versus Intrathecal in Spinal Anesthesia NCT05470530 · started 2022 · scored riskier than 5% of active trials completed
- Effect of TAP Block on Time Required for First Analgesic Dose After Cesarean Cection Under Spinal Anesthesia NCT04623632 · started 2020 · scored riskier than 10% of active trials completed
- MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section NCT06513013 · started 2023 · scored riskier than 7% of active trials completed
- Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients NCT01414777 · started 2009 · scored riskier than 14% of active trials completed
- Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section NCT06318546 · started 2024 · scored riskier than 6% 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.