Observational studyBMC pregnancy and childbirth2022
Fetal adverse effects following NSAID or metamizole exposure in the 2nd and 3rd trimester: an evaluation of the German Embryotox cohort.
Observational study in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses 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.
The trial behind it
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Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Maternal Exposure to Medications and the Risk of Congenital and Early-Onset Hearing Loss in Children: A Systematic Review and a Meta-Analysis.Basic & clinical pharmacology & toxicology · 2025Pooled it
- Adverse effects of dipyrone (Metamizole) use during pregnancy on offspring health: a systematic review and meta-analysis.BMC pregnancy and childbirth · 2025Pooled it
- Position statement on the management of pregnancy in sickle cell disease.The Australian & New Zealand journal of obstetrics & gynaecology · 2025Guideline
- Maternal Dipyrone Exposure and Risk of Major Congenital Malformations, Adverse Perinatal and Postnatal Outcomes: A Population-Based Cohort Study.Clinical pharmacology and therapeutics · 2026Article
- Development and Launch of a Dutch Mobile App (MediMama) on Over-the-Counter Medication Safety During Pregnancy and Breastfeeding: Development and Usability Study.JMIR mHealth and uHealth · 2026Article
- Assessment of Potential Exposure to Pregnancy-Contraindicated Medications Among Women of Reproductive Age in Japan: A Retrospective Database Study.Pharmacy (Basel, Switzerland) · 2026Article
- Prenatal NSAIDs exposure and childhood kidney disease: a systematic review and meta-analysis.Frontiers in pediatrics · 2026Review
- Prevalence and predictors of analgesic use during early pregnancy in a Brazilian population.Frontiers in pharmacology · 2026Article
- Fetal ductus arteriosus constriction following maternal analgesic exposure.Case reports in perinatal medicine · 2026Article
- Successful internal fixation of a pelvic ring fracture during pregnancy: a multidisciplinary case report.BMC pregnancy and childbirth · 2025Article
- Saudi Clinical Practice Guidelines for Management of Axial Spondyloarthritis Disease.Rheumatology and therapy · 2025Article
- Rheumatoid Arthritis and Pregnancy: Managing Disease Activity and Fertility Concerns.Seminars in reproductive medicine · 2024Review
- Metamizole in the Management of Musculoskeletal Disorders: Current Concept Review.Journal of clinical medicine · 2024Review
- Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNon-steroidal anti-inflammatory drugs (NSAID) are frequently used to treat pain, fever and inflammatory conditions. Due to evidenced fetotoxicity, treatment with NSAID and metamizole should be avoided in the 3rd trimester of pregnancy. There is an ongoing debate on fetotoxic risk of 2nd trimester use which is why we have conducted this study.
methodsIn this observational cohort study outcome of pregnancies with NSAID and/or metamizole exposure in the 2nd and/or 3rd trimester (study cohort n = 1092) was compared with pregnancies exposed to NSAID and/or metamizole in the 1st trimester only (comparison cohort, n = 1154). The WHO-UMC system was used to assess causality between study medication and study endpoints. Prenatal study endpoints were constriction of ductus arteriosus Botalli, oligohydramnios, late spontaneous abortion (SAB) or stillbirth. Postnatal study endpoints were patent ductus arteriosus (PDA), anomalies of the right heart ventricle, primary pulmonary hypertension (PPHT), and neonatal impairment of kidney function.
resultsDuctus arteriosus constriction was diagnosed in 5/1092 (0.5%) in the study cohort versus 0/1154 pregnancies in the comparison cohort. In one fetus, ductus arteriosus constriction and oligohydramnios occurred already in the late 2nd trimester after long-term NSAID exposure. Oligohydramnios was diagnosed in 41/1092 (3.8%) in the study cohort versus 29/1154 (2.5%) cases in the comparison cohort [RR, 1.5 (95% CI 0.9-2.4)]. Limited to 2nd trimester, oligohydramnios occurred in 8/904 (0.9%) versus 2/1154 (0.2%) pregnancies [RR, 5.1 (95% CI 1.1-24.0)]. At least in four of the 2nd trimester exposed pregnancies NSAID exposure lasted several weeks. Late SAB or stillbirth occurred in 14/1092 (1.3%) versus 17/1154 (1.5%). Postnatal cardiovascular or renal pathology did not differ between the cohorts.
conclusionsNSAID use in the 2nd trimester limited to a few days does not appear to pose a relevant risk. Use for longer periods in the advanced 2nd trimester, however, may cause oligohydramnios and ductus arteriosus constriction similar to effects observed after 3rd trimester use.
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