Evaluation of gestational age and admission date assumptions used to determine prenatal drug exposure from administrative data

Pharmacoepidemiol Drug Saf. 2005 Dec;14(12):829-36. doi: 10.1002/pds.1100.


Objective: Our aim was to evaluate the 270-day gestational age and delivery date assumptions used in an administrative dataset study assessing prenatal drug exposure compared to information contained in a birth registry.

Study design and setting: Kaiser Permanente Colorado (KPCO), a member of the Health Maintenance Organization (HMO) Research Network Center for Education and Research in Therapeutics (CERTs), previously participated in a CERTs study that used claims data to assess prenatal drug exposure. In the current study, gestational age and deliveries information from the CERTs study dataset, the Prescribing Safely during Pregnancy Dataset (PSDPD), was compared to information in the KPCO Birth Registry. Sensitivity and positive predictive value (PPV) of the claims data for deliveries were assessed. The effect of gestational age and delivery date assumptions on classification of prenatal drug exposure was evaluated.

Results: The mean gestational age in the Birth Registry was 273 (median = 275) days. Sensitivity of claims data at identifying deliveries was 97.6%, PPV was 98.2%. Of deliveries identified in only one dataset, 45% were related to the gestational age assumption and 36% were due to claims data issues. The effect on estimates of prevalence of prescribing during pregnancy was an absolute change of 1% or less for all drug exposure categories. For Category X, drug exposures during the first trimester, the relative change in prescribing prevalence was 13.7% (p = 0.014).

Conclusion: Administrative databases can be useful for assessing prenatal drug exposure, but gestational age assumptions can result in a small proportion of misclassification.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Databases, Factual*
  • Delivery, Obstetric
  • Drug Prescriptions / statistics & numerical data*
  • Drug Therapy / statistics & numerical data
  • Evaluation Studies as Topic
  • Female
  • Gestational Age*
  • Health Maintenance Organizations
  • Humans
  • Pregnancy / statistics & numerical data*
  • Prenatal Care
  • Registries*
  • Research Design