ArticlePharmacoepidemiology and drug safety2016
Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies.
Article in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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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.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Maternal exposure to sulfonamides and adverse pregnancy outcomes: A systematic review and meta-analysis.PloS one · 2020Pooled it
- A RARE CASE OF DISCORDANT ANOMALY IN A DICHORIONIC DIAMNIOTIC TWIN PREGNANCY: TESSIER CLEFT WITH SEVERE HYDROCEPHALUS IN A LOW RESOURCE SETTING.Annals of Ibadan postgraduate medicine · 2025Article
- Comparison of Linked EHR-Pharmacy Data and Administrative Claims Data: Medication Fills During Pregnancy.Pharmacoepidemiology and drug safety · 2025Article
- First-Trimester Antibiotic Use for Urinary Tract Infection and Risk of Congenital Malformations.JAMA network open · 2025Article
- Development and evaluation of an algorithm to link mothers and infants in two US commercial healthcare claims databases for pharmacoepidemiology research.BMC medical research methodology · 2023Article
- Human Listeriosis.Clinical microbiology reviews · 2023Review
- A quest for genetic causes underlying signaling pathways associated with neural tube defects.Frontiers in pediatrics · 2023Review
- Maternal and neonatal outcomes of antihypertensive treatment in pregnancy: A retrospective cohort study.PloS one · 2022Article
- Building a Data Linkage Foundation for Mother-Child Pharmacoepidemiology Research.Pharmaceutical medicine · 2021Article
- Folic acid antagonist use before and during pregnancy and risk for selected birth defects.Birth defects research · 2020Article
- Urinary Tract Infections among Indonesian Pregnant Women and Its Susceptibility Pattern.Infectious diseases in obstetrics and gynecology · 2020Article
- Safe Expectations: Current State and Future Directions for Medication Safety in Pregnancy Research.Clinical therapeutics · 2019Article
- Maternal genitourinary infections and risk of birth defects in the National Birth Defects Prevention Study.Birth defects research · 2018Article
- Use of trimethoprim-sulfamethoxazole during pregnancy and risk of spontaneous abortion: a nested case control study.British journal of clinical pharmacology · 2018Article
- Administrative Claims Data Versus Augmented Pregnancy Data for the Study of Pharmaceutical Treatments in Pregnancy.Current epidemiology reports · 2017Review
- Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011.Birth defects research. Part A, Clinical and molecular teratology · 2016Article
- Dose Dependent Effect of Sulfamethoxazole on Inhibiting KDose-response : a publication of International Hormesis SocietyArticle
Corrections and comments
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Authors and funding
21 authors at 11 institutions in 2 countries.
Funding
Abstract
backgroundSulfonamide antibacterials are widely used in pregnancy, but evidence about their safety is mixed. The objective of this study was to assess the association between first-trimester sulfonamide exposure and risk of specific congenital malformations.
methodsMother-infant pairs were selected from a cohort of 1.2 million live-born deliveries (2001-2008) at 11 US health plans comprising the Medication Exposure in Pregnancy Risk Evaluation Program. Mothers with first-trimester trimethoprim-sulfonamide (TMP-SUL) exposures were randomly matched 1:1 to (i) a primary comparison group (mothers exposed to penicillins and/or cephalosporins) and (ii) a secondary comparison group (mothers with no dispensing of an antibacterial, antiprotozoal, or antimalarial medication during the same time period). The outcomes were cardiovascular abnormalities, cleft palate/lip, clubfoot, and urinary tract abnormalities.
resultsWe first identified 7615 infants in the TMP-SUL exposure group, of which 7595 (99%) were exposed to a combination of TMP-SUL and the remaining 1% to sulfonamides alone. After matching (1:1) to the comparator groups and only including those with complete data on covariates, there were 20 064 (n = 6688 per group) in the primary analyses. Overall, cardiovascular defects (1.52%) were the most common and cleft lip/palate (0.10%) the least common that were evaluated. Compared with penicillin/cephalosporin exposure, and no antibacterial exposure, TMP-SUL exposure was not associated with statistically significant elevated risks for cardiovascular, cleft lip/palate, clubfoot, or urinary system defects.
conclusionsFirst-trimester TMP-SUL exposure was not associated with a higher risk of the congenital anomalies studied, compared with exposure to penicillins and/or cephalosporins, or no exposure to antibacterials.
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Registered trials
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