ArticleDrug safety2026
Antiemetic Combination Use During the First Trimester and Adverse Circulatory Outcomes in Newborn Infants: A Data-Mining Analysis.
Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPregnant women sometimes need antiemetic combination therapy to control severe nausea and vomiting during pregnancy. Because promethazine, ondansetron, and metoclopramide have QT-prolonging effects, combination use may potentiate arrhythmic effects in mothers and cause circulatory conditions in infants, with promethazine combinations expected to exert stronger effects than metoclopramide combinations.
objectiveWe implemented tree-based scan statistics to screen for signals of adverse circulatory-related conditions in newborn infants following maternal exposure to promethazine-ondansetron combination compared to metoclopramide-ondansetron combination.
methodsWe used Merative® Marketscan® Commercial Claims 2005-19 and Medicaid Analytic eXtract data 2005-15 to identify pregnant women aged 12-55 years with a live birth. To define combination use, pregnant women had to fill a prescription for a second antiemetic during the active days' supply of the first antiemetic and then refill the first antiemetic during the active days' supply of the second antiemetic. Our outcomes included circulatory diseases, individually and clustered within a hierarchical tree structure. We adjusted for potential confounders using propensity score quartile stratification and used Poisson tree-based scan statistics to screen for signals (p < 0.05).
resultsA total of 6865 and 4186 live birth deliveries with first-trimester exposure to promethazine-ondansetron combination or metoclopramide-ondansetron combination, respectively, met our inclusion criteria. After multiplicity adjustment for over 300 outcome clusters, we found three significant signals: unspecified hypotension (relative risk = 3.71, p < 0.001), chest pain (relative risk = 2.01, p < 0.001), and essential hypertension (relative risk = 1.76, p = 0.002) among infants with maternal promethazine-ondansetron combination exposure. Unspecified hypotension likely reflects neonatal conditions, whereas unspecified chest pain and essential hypertension may represent maternal conditions based on the claims origin.
conclusionsBy scanning more than 300 infant circulatory-related outcomes, we identified unspecified hypotension as a potential safety signal among newborns whose mothers were exposed to promethazine-ondansetron combination rather than metoclopramide-ondansetron combination during the first trimester. This finding warrants further investigation and illustrates the utility of tree-based scan statistics as a hypothesis-generating tool for pregnancy medication safety research.
Identifiers
42611119What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.