Risk of abnormal pregnancy outcomes after using Ondansetron during
pregnancy: a systematic review and Meta-analysis
Abstract
Background Hyperemesis gravidarum (HG) is a severe complication of
pregnancy affecting around 1% of pregnancies globally. Objective To
investigate whether ondansetron use during pregnancy is associated with
increased rates of abnormal pregnancy outcomes. Search strategy PubMed,
Embase, the Cochrane Library, CINAHL, CNKI, CBM, WANFANG, and
ClinicalTrials.gov were searched for citations published in any language
from inception to 15 December 2021. Selection criteria Eligible studies
included any observational study. Data collection and analysis We used
odds ratios (ORs) and 95% confidence intervals (CIs) as a measure of
the association between ondansetron and abnormal pregnancy outcomes.
Main results Of 1,558 citations screened, 19 articles were included. No
significant increased risk for overall congenital malformations
(OR=1.10,95% CI:0.94–1.29, Low certainty), cleft palate (OR=0.78,95%
CI:0.37–1.64, Very Low certainty), stillbirth (OR=0.60,95%
CI:0.40–0.91, Low certainty) or preterm birth (OR=0.78,95%
CI:0.37–1.64, Low certainty) were identified in our primary analysis.
However, the results of our primary analysis indicated that ondansetron
use during pregnancy was associated with significantly increased rates
of heart defects (OR=1.06,95% CI:1.02–1.11, Moderate certainty) and
other organ malformations (OR=1.09,95% CI:1.03–1.16, Moderate
certainty) when exposed infants were compared with healthy or
disease-matched controls. Conclusion Ondansetron use during pregnancy
was associated with a significant increase in rate of some abnormal
pregnancy outcomes in our primary analysis. In conclusion, our review
found that ondansetron should not use as first-line treatment for NVP.
But for sever and incurable NVP, clinician can consider use moderate
amount ondansetron to treat NVP with close monitoring.