ArticleAnnals of epidemiology2017
Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011.
Article in Annals of epidemiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07595302 (Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain), which is not on this map. Cited by 42 papers, 3 of them syntheses that pooled it.
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.
Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)
Who cites it
42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 104 citations in OpenAlex.
- Use of sensitivity analyses to assess uncontrolled confounding from unmeasured variables in observational, active comparator pharmacoepidemiologic studies: a systematic review.American journal of epidemiology · 2025Pooled it
- Physical job demands in pregnancy and associated musculoskeletal health and employment outcomes: a systematic review.American journal of obstetrics and gynecology · 2024Pooled it
- Medication use during pregnancy and the risk of gastroschisis: a systematic review and meta-analysis of observational studies.Orphanet journal of rare diseases · 2024Pooled it
- Maternal Dipyrone Exposure and Risk of Major Congenital Malformations, Adverse Perinatal and Postnatal Outcomes: A Population-Based Cohort Study.Clinical pharmacology and therapeutics · 2026Article
- First-trimester nonsteroidal anti-inflammatory drugs exposure and risk of major congenital malformations: A retrospective register-based cohort study.PLoS medicine · 2026Article
- Paracetamol in Pregnancy: Reassurance Amidst Uncertainty.BJOG : an international journal of obstetrics and gynaecology · 2026Article
- USP9X as a Candidate Mediator of Prenatal Aspirin-Induced Ovarian Reserve Reduction in Offspring Mice.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Prescription use of acetaminophen among pregnant women in Denmark from 2000 to 2023: A drug utilization study.British journal of clinical pharmacology · 2026Article
- Paracetamol exposure during pregnancy, the risk of major congenital malformations, and perinatal and postnatal outcomes: a population-based cohort study.Human reproduction open · 2026Article
- Article
- Real-world data are not always big data: the case for primary data collection on medication use in pregnancy in the context of birth defects research.American journal of epidemiology · 2024Article
- Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching.BMC pregnancy and childbirth · 2024Article
- Environmental Signals.Advances in experimental medicine and biology · 2024Article
- Public health priorities for gastroschisis: Summary of a meeting sponsored by the Centers for Disease Control and Prevention and the March of Dimes.Birth defects research · 2024Article
- Patterns of Prescription Medication Use during the First Trimester of Pregnancy in the United States, 1997-2018.Clinical pharmacology and therapeutics · 2023Article
- Maternal cyclobenzaprine exposure and risk of birth defects in the National Birth Defects Prevention Study (1997-2011) and Birth Defects Study to Evaluate Pregnancy exposureS (2014-2018).Pharmacoepidemiology and drug safety · 2023Article
- The molecular mechanisms in prenatal drug exposure-induced fetal programmed adult cardiovascular disease.Frontiers in pharmacology · 2023Review
- A quest for genetic causes underlying signaling pathways associated with neural tube defects.Frontiers in pediatrics · 2023Review
- The Main Changes in Pregnancy-Therapeutic Approach to Musculoskeletal Pain.Medicina (Kaunas, Lithuania) · 2022Review
- Medication use during pregnancy among women with congenital physical disabilities.Birth defects research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
purposeTo compare the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or opioids to the use of acetaminophen without NSAIDs or opioids with respect to associations with birth defects.
methodsWe used data from the National Birth Defects Prevention Study (1997-2011). Exposure was self-reported maternal analgesic use from the month before through the third month of pregnancy (periconceptional). Adjusted odds ratios (aORs) were calculated to examine associations with 16 birth defects.
resultsCompared to acetaminophen, mothers reporting NSAIDs were significantly more likely to have offspring with gastroschisis, hypospadias, cleft palate, cleft lip with cleft palate, cleft lip without cleft palate, anencephaly, spina bifida, hypoplastic left heart syndrome, pulmonary valve stenosis, and tetralogy of Fallot (aOR range, 1.2-1.6). Opioids were associated with tetralogy of Fallot, perimembranous ventricular septal defect, and ventricular septal defect with atrial septal defect (aOR range, 1.8-2.3), whereas use of both opioids and NSAIDs was associated with gastroschisis, cleft palate, spina bifida, hypoplastic left heart syndrome, and pulmonary valve stenosis (aOR range, 2.0-2.9).
conclusionsCompared to periconceptional use of acetaminophen, selected birth defects occurred more frequently among infants of women using NSAIDs and/or opioids. However, we could not definitely determine whether these risks relate to the drugs or to indications for treatment.
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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.