Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 11% of the time (234 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-03-01, after 2015-08-31 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 2017-03-01. 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: pretermprogesteronetherapycordto determine
Phrases that lowered it: efficacysinglecomparisonoralweeks -
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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Phase: 3 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Blinding: single (lowers risk) · Design
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Drug's FAERS reports marked serious: 65.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 2.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: not given (raises risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Sponsor type: government (raises risk) · Sponsor's track record
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (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
- government (typical: 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
- 5309 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 914 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- dydrogesterone, progesterone
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
- Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial NCT00946088 · started 2009 · scored riskier than 89% of active trials terminated
- Nifedipine for Acute Tocolysis of Preterm Labor NCT02132533 · started 2014 · scored riskier than 70% of active trials completed
- Vaginal Progesterone in Twin With Short Cervix NCT02697331 · started 2016 · scored riskier than 5% of active trials completed
- Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation NCT01577121 · started 2012 · scored riskier than 20% of active trials completed
- Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth NCT02350231 · started 2014 · scored riskier than 11% 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.