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Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Neural tube defect risk in relation to opioid analgesic exposure during early pregnancy
Denise M Boudreau1, Gaia Pocobelli1, Jennifer F Bobb1
1Kaiser Permanente Washington Health Research Institute, Kaiser Permanente Washington, Seattle, WA, United States.
Insights
This study found no definitive link between early pregnancy opioid use and neural tube defects (NTDs). More research is needed to confirm or refute this potential risk for birth defects.
Area of Science:
- Obstetrics and Gynecology
- Teratology
- Pharmacoepidemiology
Background:
- Prescription opioid analgesic use during pregnancy is a growing concern.
- The potential association between early pregnancy opioid exposure and neural tube defects (NTDs) requires further investigation.
Purpose of the Study:
- To evaluate the risk of NTDs in infants born to mothers who used prescription opioid analgesics during early pregnancy.
- To compare NTD risks between opioid-exposed and unexposed pregnancies.
Main Methods:
- A cohort study was conducted using data from nine U.S. health plans (2001-2014).
- Liveborn singletons were analyzed for primary NTDs (anencephaly, select spina bifida) and any NTD.
- Maternal new opioid use during 18-56 days post-LMP was compared to no maternal use.
Main Results:
- Adjusted odds ratios (ORs) for primary NTD and any NTD were 3.0 (95% CI: 0.7, 12.7) and 2.3 (95% CI: 0.8, 6.7), respectively.
- Sensitivity analyses yielded similar ORs (2.4 and 1.6).
- Increased ORs in the main analysis were potentially influenced by residual confounding.
Conclusions:
- The study results do not conclusively support or refute the hypothesis linking early pregnancy opioid exposure to increased NTD risk.
- Residual confounding may explain the observed associations.
- Larger, well-powered studies with robust confounder adjustment are needed but present significant challenges.
Abstract:
We evaluated neural tube defect (NTD) risk associated with prescription opioid analgesic use during early pregnancy. We conducted a cohort study of liveborn singletons during 2001-2014 among 9 U.S. health plans. Risks of medical chart-confirmed primary NTD (anencephaly and select spina bifida) and any NTD (primary and other NTD) were compared among singletons with maternal new use of opioids during 18-56 days after last menstrual period to those with no maternal use during this period or pre-pregnancy. In a sensitivity analysis, singletons exposed during the second or third trimesters only ("negative control exposure") were compared to those never exposed. The main analysis adjusted odds ratio (OR) associated with exposure was 3.0 (95% CI, 0.7-12.7) for primary NTD and 2.3 (95% CI, 0.8-6.7) for any NTD. The sensitivity analysis ORs were similar 2.4 and 1.6, respectively. Our results do not support or refute the hypothesis that prescription opioid analgesic exposure in early pregnancy increases risk of NTD. Although ORs were increased in the main analysis, the sensitivity analysis suggested the presence of residual confounding. Future studies that are sufficiently powered and adjust for confounders beyond those in the present study are warranted but likely challenging.
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