Botulinum Toxin Treatment in Pregnant Laryngeal Dystonia Patients: Case Series and Survey of Current Practice of Canadian Laryngologists
Bibliographic record
Abstract
ImportanceOnabotulinumtoxin A (BTX) is the first-line treatment for laryngeal dystonia (LD). The US FDA designated BTX as a pregnancy category C drug because there are no well-controlled studies in pregnant women.ObjectivesTo describe pregnancy and neonatal outcomes in pregnant LD patients treated with BTX injections and to assess the current practice and comfort level of Canadian laryngologists in treating these patients.DesignCase Series and Survey.SettingAcademic, tertiary care, laryngology center.ParticipantsPregnant women who received BTX for LD from 2010 to 2020.InterventionA retrospective chart review was conducted for eligible patients. An anonymous, online, cross-sectional survey was distributed to Canadian laryngologists, according to Dillman's Total Design method.Main outcome measuresPregnancy and neonatal outcomes.ResultsFour adductor LD patients received BTX during each of their 2 pregnancies; 8 pregnancies were examined. Patients received a median of 4.5 treatments (IQR 3) with a median cumulative dose of 5.12 U (IQR 2.93 U) over the whole pregnancy. One pregnancy was pre-term and the median APGAR score was 9 (IQR 0.5). All mothers breastfed their infants. There were no adverse events (AE) and all children were healthy, with a median age of 7 (IQR 2). Twenty-three Canadian laryngologists responded to the survey, for an 85.2% response rate. Three laryngologists (13.0%) have previously injected BTX in a total of 5 pregnant women. All 5 pregnancies went to term with no AE. The majority (68.4%) of respondents indicated that they would offer BTX injections to pregnant LD patients after obtaining informed consent.ConclusionThis case series was the largest in the literature of pregnant LD patients undergoing BTX treatment. The majority of Canadian laryngologists would offer the procedure to pregnant women with informed consent.RelevanceThis study added to the growing literature on the safety of BTX injections in LD patients during pregnancy.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".