Balloon to Induce Labor in Generous Women.
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 15% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (159 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-02-02, after 2020-06-26 start.
Reason given by the sponsor: “other”
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 2023-02-02. 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) (lowers risk) · Wording
Phrases that raised it: inductiontyperatepatientsubject
Phrases that lowered it: weightinfectionbleedingµghiv -
Primary purpose: other (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 13.2% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 6.4% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 64.7% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 67 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: single (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Design: parallel (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (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
- 220 (typical: 32)
- Sponsor's past termination rate
- 13.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 67 (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
- 14047 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1296 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital
- Drugs matched to FDA substances
- misoprostol
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
- Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women NCT06217354 · started 2023 · scored riskier than 6% of active trials completed
- Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin NCT03138252 · started 2014 · scored riskier than 30% of active trials completed
- A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening NCT03806231 · started 2019 · scored riskier than 31% of active trials terminated
- Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies NCT02907060 · started 2017 · scored riskier than 73% of active trials completed
- Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies NCT00930618 · started 2009 · scored riskier than 58% 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.