STUDY OF POSSIBLE TERATOLOGIC EFFECTS FROM DRUGS

Project Details

Description

If one were to examine any recent edition of the Physicians' Desk
Reference (PDR), virtually all drugs are recommended to be
avoided in pregnancy, not because of known problems but because
of a lack of information. Yet, data available from several surveys
document a remarkably high number of drugs used in pregnancy.
Although it is often assumed that only a small proportion of total
birth defects are attributable to drugs, this remains to be
documented. The proposed study will use COMPASS, an extremely
large database (over 8 million subjects) containing Medicaid
billing data, to address this question. The study consists of four
parts: a descriptive study, a series of screening population-based
case-control studies, a series of confirmatory population-based
case-control studies, and a series of validation studies. The initial phase of this study will evaluate the patterns of drug
use during pregnancy for this Medicaid population. We will
evaluate use by state, by age group, by race, and by trimester.
The experience of a total of 235,000 pregnancies will be used for
this part of the study. The second part of the proposed study is a series of retrospective
case-control investigations to screen for possible associations
between the use of drugs in pregnancy and birth defects. In this
study, cases with birth defects, in general, will be compared to an
equal number of randomly selected normal infants, matched for
state and maternal age, looking for differences in first trimester
in utero drug exposure. Subsequent analyses will then look at
specific defects. The third part of the study we will examine the associations which
emerge from these screens as well as a series of a priori
hypotheses, in more detail, using stratification and logistic
regression to control for confounding and search for effect
modification. Finally, a series of validation studies will be performed. We will
request primary medical records from health care providers
through each state's Medicaid program. Information will be
sought regarding diagnoses, including complications of pregnancy,
drugs, birth weight, parity, gestational age, drug abuse, smoking,
and alcohol exposures. This study will enable us to quantify errors
due to misclassification and due to under-recording in the
Medicaid billing data. We will also be able to estimate the effect
of potential confounders not evaluated with COMPASS data.
StatusFinished
Effective start/end date7/1/886/30/92

Funding

  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health

ASJC

  • Medicine(all)

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