# Maternal use of prescribed opioid analgesics and risk of adverse offspring outcomes

> **NIH NIH R01** · TRUSTEES OF INDIANA UNIVERSITY · 2021 · $9,193

## Abstract

Prescribed opioid analgesic (POA) use for the treatment of pain is common among women of childbearing age
and pregnant women. Despite its prevalence, however, little is known about the effects of POA use in
pregnancy on offspring development. Findings from the few observational studies of POA use in pregnancy
and birth outcomes are mixed and limited by poor study quality, including inadequate control for confounding.
The current proposal seeks to address these limitations through comprehensive analysis of a large population-
based sample. In particular, the objective of the current proposal is to improve our understanding of the use
and safety of POAs in pregnancy, focusing on adverse birth outcomes (structural birth defects, small size for
gestational age, and preterm birth) and neurodevelopmental disorders (autism spectrum and attention-
deficit/hyperactivity disorders). We propose to analyze an unparalleled, nation-wide dataset of 1.25 million
Swedish children born 2006-2017, which includes detailed assessment of POA use in pregnancy, birth
outcomes and neurodevelopmental disorders, and a wide range of factors that could influence the likelihood of
both treatment and offspring outcomes. Furthermore we propose to use and combine multiple advanced
methods of analysis. In addition to adjustment for measured factors, we will use several types of comparison
groups to help evaluate the role of unmeasured confounding, including siblings, offspring of mothers using
another pain medication, and offspring of mothers using POAs before but not during pregnancy. Finally, we
also will evaluate the associations with paternal POA use during pregnancy as a negative control. Preliminary
analyses demonstrating that POA use during pregnancy is associated with adverse offspring outcomes, but
also with many psychiatric and socioeconomic factors associated with the offspring outcomes, highlight the
importance of our proposal. The proposed research is significant because it will provide a greater description of
the patient characteristics that influence POA use during pregnancy, as well as a better understanding of the
specific risks of the practice for offspring outcomes associated with significant morbidity and mortality. The
proposal is innovative due to (a) the use of unparalleled data drawn from the linkage of numerous national
registers that provide precise measures for key constructs; (b) the use of multiple advanced methods and
systematic evaluation of the validity of their assumptions; and (c) a unique interdisciplinary team of
researchers. The results will provide critical information for medical decision-making regarding the pain
management with POAs in pregnancy and among women of childbearing age, inform ensuing research to
identify offspring at greatest risk of adverse outcomes related to POA use, and guide subsequent basic
research into mechanisms behind the effects of fetal opioid exposure. This supplement will support a student
as she assists us on t...

## Key facts

- **NIH application ID:** 10400407
- **Project number:** 3R01DA048042-03S1
- **Recipient organization:** TRUSTEES OF INDIANA UNIVERSITY
- **Principal Investigator:** Brian M D'Onofrio
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $9,193
- **Award type:** 3
- **Project period:** 2019-04-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10400407

## Citation

> US National Institutes of Health, RePORTER application 10400407, Maternal use of prescribed opioid analgesics and risk of adverse offspring outcomes (3R01DA048042-03S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10400407. Licensed CC0.

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