Neurocognitive Development of Children Exposed to Doxylamine–Pyridoxine Combination In Utero for Morning Sickness
Bibliographic record
Abstract
INTRODUCTION: Nausea and vomiting of pregnancy affect up to 90% of all pregnancies. Diclectin and Diclegis (delayed-release 10 mg doxylamine–10 mg pyridoxine combination) is the only antiemetic approved in the United States and Canada for nausea and vomiting of pregnancy at a maximum dose of 4 tablets per day. However, some women receive off-label higher doses, up to 12 tablets per day. The objective of this study was to assess long-term neurodevelopmental fetal safety of this drug combination. METHODS: We compared the neurocognitive development of children from four mother–child groups: 1) nausea and vomiting of pregnancy treated with more than four tablets of Diclectin (n=41); 2) nausea and vomiting of pregnancy treated with up to four tablets per day of Diclectin (n=84); 3) nausea and vomiting of pregnancy and no treatment (n=63); and 4) no nausea and vomiting of pregnancy (n=49). Children received a full age-appropriate psychological assessment at 3–7 years of age. RESULTS: Children of all four groups scored in the normal range for IQ, language, temperament, and behavior. The children whose mothers experienced nausea and vomiting of pregnancy achieved significantly higher scores on some subscales of cognition, language, and behavior, correlating with the severity of the nausea and vomiting of pregnancy. The Diclectin-exposed groups scored significantly higher on a small number of subtests, but none of the differences could be considered clinically significant and no dose-dependent effects were observed. CONCLUSIONS: Diclectin does not appear to harm neurodevelopment even at off-label supradoses and should be considered safe for the treatment of nausea and vomiting of pregnancy. The severity of nausea and vomiting of pregnancy correlates positively with neurodevelopmental achievements.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".