title: Pivmecillinam and adverse birth and neonatal outcomes: a population-based cohort study.
abstract: A previous study unexpectedly showed an increased, statistically imprecise, risk of low Apgar score in children of women redeeming prescriptions for pivmecillinam in late pregnancy. To improve statistical precision we extended the previous dataset with data for 5 more y, and in addition added more neonatal outcomes. We thus examined the risk of adverse birth and neonatal outcomes among pregnant users of pivmecillinam based on population-based registries in North Jutland County, Denmark. We included 63,659 women with a live birth, or stillbirth after the 28th week of gestation. 2031 had redeemed prescriptions for pivmecillinam any time during pregnancy, 559 in the first trimester and 371 within 28 d before delivery. Adjusted odds ratios were: birth defects 0.83 (95% confidence interval (95% CI) 0.53-1.32) for exposure during first trimester, preterm delivery 0.96 (95% CI 0.79-1.18) and low birth weight 0.79 (95% CI 0.52-1.20) for exposure any time during pregnancy, and stillbirth 1.19 (95% CI 0.30-4.80), low Apgar score 1.17 (95% CI 0.37-3.66), hypoglycaemia 1.03 (95% CI 0.53-2.00), and respiratory distress syndrome 0.79 (95% CI 0.38-1.68) for exposure within 28 d before delivery. Use of pivmecillinam during pregnancy did not appear to increase the risk of adverse birth and neonatal outcomes; however, statistical precision is still low.
authors.affiliation: Department of Clinical Epidemiology, Aarhus University Hospital, DK-8000 Aarhus C, Denmark. mvs@soci.au.dk
authors.forename: Mette
authors.initials: M
authors.lastname: Vinther Skriver
authors.forename: Mette
authors.initials: M
authors.lastname: Nørgaard
authors.forename: Lars
authors.initials: L
authors.lastname: Pedersen
authors.forename: Henrik
authors.initials: H
authors.lastname: Carl Schønheyder
authors.forename: Henrik Toft
authors.initials: HT
authors.lastname: Sørensen
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000175:diagnosis / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D000561:Amdinocillin Pivoxil / Q000009:adverse effects* / Q000627:therapeutic use; D001034:Apgar Score; D015331:Cohort Studies; D016001:Confidence Intervals; D003718:Denmark / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D016015:Logistic Models; D016017:Odds Ratio; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D047928:Premature Birth; D018570:Risk Assessment
chemical_list: D000561:Amdinocillin Pivoxil