Prenatal triptan exposure and parent-reported early childhood neurodevelopmental outcomes: an application of propensity score calibration to adjust for unmeasured confounding by migraine severity

Pharmacoepidemiol Drug Saf. 2016 May;25(5):493-502. doi: 10.1002/pds.3902. Epub 2015 Nov 11.

Abstract

Purpose: Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of triptans during pregnancy are scant. We sought to quantify the association of prenatal triptan exposure on neurodevelopment in 3-year-old children.

Methods: Using data from the Norwegian Mother and Child Cohort Study, we used propensity score matching to examine associations between prenatal triptan exposure and psychomotor function, communication, and temperament. We used an external validation study to perform propensity calibration to adjust effect estimates for confounders unmeasured in the main study (migraine severity, type, and maternal attitudes towards medication use).

Results: We identified 4204 women who reported migraine headache at baseline, of which 375 (8.9%) reported using a triptan greater than or equal to once during pregnancy. Children with prenatal triptan exposure had 1.37-fold greater unadjusted odds of fine motor problems (95% confidence interval (CI): 1.06-1.77), which decreased after propensity score matching (odds ratio (OR): 1.29, 95%CI 0.97-1.73) and was further attenuated after calibration (OR: 1.25, 95%CI 0.89-1.74). We observed no increased risk for gross motor or communication problems, and no differences in temperament. Adjustment for migraine severity using propensity score calibration had a moderate impact on effect estimates, with percent changes ranging from 2.4% to 50%.

Conclusions: Prenatal triptan exposure was not associated with psychomotor function, communication problems, or temperament in 3-year-old children. Adjustment for migraine severity reduced effect estimates and should be considered in future studies of the safety of triptans during pregnancy. Copyright © 2015 John Wiley & Sons, Ltd.

Keywords: child neurodevelopment; migraine; pharmacoepidemiology; pregnancy medication; propensity score calibration.

Publication types

  • Validation Study

MeSH terms

  • Adult
  • Child, Preschool
  • Chronic Disease
  • Cohort Studies
  • Confounding Factors, Epidemiologic
  • Female
  • Humans
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / physiopathology
  • Neurodevelopmental Disorders / epidemiology*
  • Neurodevelopmental Disorders / etiology
  • Norway
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Complications / physiopathology
  • Prenatal Exposure Delayed Effects / epidemiology*
  • Propensity Score
  • Severity of Illness Index
  • Tryptamines / administration & dosage
  • Tryptamines / adverse effects*

Substances

  • Tryptamines