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

> **NIH NIH R01** · TRUSTEES OF INDIANA UNIVERSITY · 2021 · $397,357

## 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. Animal models demonstrate that prenatal opioid exposure can alter brain
development and behavior, but whether this translates to risks for neurodevelopmental disorders in humans is
not known. 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 (i.e., prescribed acetaminophen as an active comparator), 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...

## Key facts

- **NIH application ID:** 10112875
- **Project number:** 5R01DA048042-03
- **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:** $397,357
- **Award type:** 5
- **Project period:** 2019-04-01 → 2024-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10112875

## Citation

> US National Institutes of Health, RePORTER application 10112875, Maternal use of prescribed opioid analgesics and risk of adverse offspring outcomes (5R01DA048042-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10112875. Licensed CC0.

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