SynthesisBMC pregnancy and childbirth2022
Opioid exposure during pregnancy and the risk of congenital malformation: a meta-analysis of cohort studies.
Synthesis in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed, 9 citations in OpenAlex.
- Protocol Commentary for the SUCCESS (Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant Participants with Opioid Use Disorder) Study.Substance use & addiction journal · 2025Article
- Prenatal Opioid Use Disorder and the Risk of Congenital Anomalies in Offspring: A Population-Based Study.Birth defects research · 2025Article
- Navigating Pregnancy Testing in Chronic Pain Management for Women of Reproductive Age.Journal of pain research · 2025Review
- Prenatal opioid exposure and subsequent risk of neuropsychiatric disorders in children: nationwide birth cohort study in South Korea.BMJ (Clinical research ed.) · 2024Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOpioid exposure during pregnancy has increased alarmingly in recent decades. However, the association between prenatal opioid exposure and congenital malformation risk has still been controversial. We aim to assess the association between opioid exposure during pregnancy and the risk of congenital malformations.
methodPubMed, Embase, and Cochrane library of clinical trials were systematically searched to September 13th, 2021. Cohort studies reporting risk of congenital malformation after opioid exposure compared with non-exposure during pregnancy were included. Risk of studies was appraised with the ROBINS-I tool. Meta-analysis was conducted using the random-effects model. Subgroup analyses were conducted for the primary outcome based on indication, exposed period, whether adjusted data was used, and risk of bias assessment. Meta-regression was performed to evaluate the relation of publication year. MAIN
resultsEighteen cohort studies with 7,077,709 patients were included. The results showed a significant increase in the risk of overall congenital malformation (RR = 1.30, 95%CI: 1.11-1.53), major malformation (RR = 1.57, 95%CI:1.11-2.22), central nervous system malformation (RR = 1.36, 95% CI:1.19-1.55), and limb malformation (RR = 2.27, 95%CI:1.29-4.02) with opioid exposure during pregnancy. However, the predictive interval conveyed a different result on overall congenital malformation (95%PI: 0.82-2.09) and major malformation (95%PI: 0.82-2.09). No association between opioid exposure and overall congenital malformation in the first trimester (RR = 1.12, 95%CI:0.97-1.31) and prescribed for analgesic or antitussive treatment (RR = 1.03, 95%CI:0.94-1.13) were observed. In subgroups that study provided data adjusted for confounders (RR = 1.06, 95%CI:0.93-1.20) or identified moderate or serious risk of bias (RR = 1.00, 95%Cl: 0.85-1.16; RR = 1.21, 95%Cl: 1.60-2.68), no association was found.
conclusionOpioid exposed in the first trimester or prescribed for analgesic or antitussive treatment did not increase the risk of overall congenital malformation. The findings should be discussed in caution considering the situation of individual patients and weigh out its potential risk of congenital malformation.
trial registrationRegistration number: CRD42021279445 .
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