TY - JOUR
T1 - Pivmecillinam and adverse birth and neonatal outcomes: a population-based cohort study
AU - Vinther Skriver, Mette
AU - Nørgaard, Mette
AU - Pedersen, Lars
AU - Carl Schønheyder, Henrik
AU - Sørensen, Henrik Toft
PY - 2004
Y1 - 2004
N2 - 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.
AB - 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.
KW - Abnormalities, Drug-Induced
KW - Adolescent
KW - Adult
KW - Amdinocillin Pivoxil
KW - Apgar Score
KW - Cohort Studies
KW - Confidence Intervals
KW - Denmark
KW - Dose-Response Relationship, Drug
KW - Drug Administration Schedule
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Incidence
KW - Infant, Low Birth Weight
KW - Infant, Newborn
KW - Logistic Models
KW - Odds Ratio
KW - Pregnancy
KW - Pregnancy Complications, Infectious
KW - Pregnancy Outcome
KW - Pregnancy Trimester, Third
KW - Premature Birth
KW - Risk Assessment
U2 - 10.1080/00365540410021072
DO - 10.1080/00365540410021072
M3 - Journal article
SN - 0036-5548
VL - 36
SP - 733
EP - 737
JO - Scandinavian Journal of Infectious Diseases
JF - Scandinavian Journal of Infectious Diseases
ER -