Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-02-01, after 2019-05-01 start.
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 2020-02-01. 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) (lowers risk) · Wording
Phrases that raised it: undergoingstudy isneurologicalpresection
Phrases that lowered it: patientsplusiiside effectsthe effect -
Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Drug's FAERS reports with a death: 35.8% (raises risk) · Drug's FDA history
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: sponsor investigator (raises risk) · Design
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Design: parallel (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 114011 (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Maximum age: 40 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Number of arms: 2 (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 40 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 114011 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20320 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 35.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fentanyl, midazolam
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
- Intrathecal Nalbuphine Versus Midazolam in Cesarean Section NCT03918187 · started 2019 · scored riskier than 5% of active trials completed
- Intrathecal Levobupivacaine With Opioids for Caesarean Section NCT01858090 · started 2009 · scored riskier than 8% of active trials completed
- Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia. NCT03458078 · started 2017 · scored riskier than 8% of active trials completed
- Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section NCT01404442 · started 2011 · scored riskier than 8% of active trials completed
- Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section NCT01425658 · started 2011 · scored riskier than 7% 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.