Birth Outcomes in Women Who Have Taken Vedolizumab in Pregnancy: Results From the Vedolizumab Pregnancy Exposure Registry
Bibliographic record
Abstract
OBJECTIVES: There are limited data on the safety of vedolizumab in pregnancy for the treatment of Crohn's disease or ulcerative colitis. Between 2015 and 2022, the Organization of Teratology Information Specialists conducted a prospective, observational pregnancy registry study with 275 pregnant women residing in the United States or Canada. METHODS: Women were enrolled in 1 of 3 cohorts: vedolizumab-exposed (N = 99); disease-matched unexposed to vedolizumab, but treated with another biologic in pregnancy (N = 76); or unexposed with no chronic health conditions (N = 100). Women and their infants were followed up to 1 year postpartum with maternal interviews, questionnaires, medical records abstraction, and a subset of infants who received a physical examination. Study outcomes were major structural birth defects, minor birth defects, pregnancy loss, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, malignancies, and developmental milestones. RESULTS: In the overall registry, 17 of 275 pregnancies (6.2%) were lost to follow-up. Among pregnancies ending in at least 1 live born infant, 7 of 94 (7.4%) in the vedolizumab-exposed cohort compared with 4 of 71 (5.6%) in the disease-matched cohort had a major birth defect (adjusted risk ratio 1.07, 95% confidence interval [CI] 0.33, 3.52). Compared with the disease-matched cohort, women in the vedolizumab-exposed group were not statistically significantly more likely to experience spontaneous abortion (adjusted hazard ratio 1.01, 95% CI 0.17, 5.89). Women in the vedolizumab-exposed group were slightly but not significantly more likely to deliver preterm (adjusted hazard ratio 1.58, 95% CI 0.65, 3.82). CONCLUSIONS: No significant increased risks were noted with vedolizumab exposure for any of the other study outcomes. These data add reassuring evidence in support of the safety of vedolizumab in 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 | 0.001 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 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".