Improving Pregnancy Outcomes With Progesterone
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (169 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-08-06, after 2018-02-07 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 2020-08-06. 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: plannedof 17pregnancyat timepreterm
Phrases that lowered it: antiretroviraltrialweeksconfirmedart -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 41.1% (lowers risk) · Drug's FDA history
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Collaborators: 3 (lowers risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Blinding: triple (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 114 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 3.8% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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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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Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 455 (lowers 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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 3 (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
- 455 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 114 (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
- 5481 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3429 (typical: 412.5)
- Drug's FAERS reports marked serious
- 41.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- hydroxyprogesterone, hydroxyprogesterone caproate
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
- Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery NCT01004029 · started 2009 · scored riskier than 30% of active trials completed
- Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth NCT03292731 · started 2018 · scored riskier than 13% of active trials terminated
- Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial. NCT01050647 · started 2010 · scored riskier than 77% of active trials completed
- Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) NCT01119963 · started 2011 · scored riskier than 9% of active trials completed
- PREGNANT Short Cervix Trial NCT00615550 · started 2008 · scored riskier than 21% 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.