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A Population-Based Study to Quantify the Risks of Opioid Analgesics in Pregnancy

Award Number: R03HD099617
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/12/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2022

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A Population-Based Study to Quantify the Risks of Opioid Analgesics in Pregnancy - PROJECT SUMMARY Prescription opioid use in pregnancy has increased dramatically over the past two decades. Yet, few studies have examined the impact of opioids used for pain on adverse pregnancy outcomes. Some data suggest that prenatal opioid analgesics may be associated with a higher risk of certain birth defects. However, evidence is limited by discrepant study results, poor maternal recall of medication use, and small sample sizes. In addition to these concerns, there are little data on the risk of preterm and small for gestational age birth following opioid analgesic exposure, and stillbirth has not been studied. Evidence of the safe use of prenatal opioid analgesics is thus inconclusive. The primary goal of this study is to determine the risks associated with exposure to opioids for pain in pregnancy independent of biases that have affected prior studies. We will examine several important adverse pregnancy outcomes possibly associated with such exposure including specific birth defects, preterm birth, small for gestational age birth, and stillbirth. The outcomes of maternal and infant opioid dependence following prenatal opioid analgesic exposure also will be evaluated. To achieve this goal we have assembled a population-based cohort of all pregnancies in Ontario, Canada (N≈790,000) from 2012-2017, 30,262 of which were exposed to opioid analgesics during pregnancy. Using modern methods such as high-dimensional propensity score adjustment and sensitivity analyses of alternative referents (including infants unexposed to opioid analgesics and infants unexposed to opioid analgesics but prenatally exposed to other analgesics), we will determine the associations between particular opioid analgesic exposures during the etiologically relevant windows of gestation and these maternal and infant outcomes. This will be the first study to examine the duration and dose of prenatal analgesic opioids on the risk of these adverse outcomes. Our population-based cohort study will provide estimates of the absolute risk of these outcomes, which cannot be estimated from existing US case-control studies, and which are needed to inform maternal treatment choices. Studies of the safety of prenatal medications in extant US data such as Medicaid exclude 80% of pregnancies (i.e., women with restricted benefits, capitated care, private insurance, or incomplete enrollment during pregnancy) to have complete pregnancy data, which may result in selection bias or results that cannot be generalized. Concerns of generalizability also apply to US private insurance beneficiaries. To overcome these limitations we propose a population-based cohort study using an extant database of universal healthcare coverage and complete prescription data for Ontario, Canada’s most populous province of 13 million. Clinical care and characteristics of pregnant women in the US and Canada are similar, thus the results of this study will have direct relevance for US providers and pregnant women. Better understanding of the risks of prenatal opioid analgesics will direct treatment of pain in pregnancy and management of exposed infants.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	QUEENS UNIVERSITY AT KINGSTON	99 UNVERSITY AVE	KINGSTON	ON			CAN	Child Health and Human Development Extramural Research	000	2	9/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $56,123 )
2020	2020	QUEEN'S UNIVERSITY AT KINGSTON	99 UNIVERSITY AVE	KINGSTON	ON	K7L 3N5		CAN	Child Health and Human Development Extramural Research	000	2	8/10/2020	NON-COMPETING CONTINUATION	$56,123
														Subtotal = $56,123

Issue Date FY: 2019 ( Subtotal = $62,031 )
2019	2019	QUEEN'S UNIVERSITY AT KINGSTON	99 UNIVERSITY AVE	KINGSTON	ON	K7L 3N5		CAN	Child Health and Human Development Extramural Research	000	1	9/12/2019	NEW	$62,031
														Subtotal = $62,031

Grand Total All Awards = $118,154

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A Population-Based Study to Quantify the Risks of Opioid Analgesics in Pregnancy

Award Number: R03HD099617

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/12/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2022

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