Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
Model scores of the 29,894 trials active now.
Model score 10% 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 14% of the time (81 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2012-01-31, after 2008-10-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-01-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: 12administered35weeksstudy
Phrases that lowered it: prophylaxispatientstrialtermactive -
Primary purpose: prevention (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Phase: 2/3 (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Responsible party: principal investigator (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Minimum age: not given (raises risk) · Who can join
-
Maximum age: not given (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 18.6% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 91.6% (raises risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
-
Blinding: none (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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- not given (typical: 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
- 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
- 2668 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 555 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, urogenital
- Drugs matched to FDA substances
- ampicillin, gentamicin
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
- Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management NCT07394725 · started 2024 · scored riskier than 9% of active trials completed
- Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane NCT01503606 · started 2011 · scored riskier than 12% of active trials completed
- Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes NCT02469519 · started 2016 · scored riskier than 25% of active trials completed
- Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity? NCT02939742 · started 2016 · scored riskier than 21% of active trials terminated
- Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin NCT01099280 · started 2009 · scored riskier than 10% 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.