Comparison of Pregnancy Outcomes between Ongoing Pregnancies after Accidental Misoprostol Use and Normal Pregnancies: A Case-control Study

Abstract

Aim: Literature reports are conflicting regarding the association of anomalies with misoprostol use. We conducted this study to assess the association of misoprostol with congenital abnormalities. Materials and methods: In this prospective case-control study, women with early pregnancy were recruited from the antenatal clinic and divided into cases and controls on the basis of exposure to misoprostol. They attended antenatal visits, delivered at the hospital, and their babies were examined for abnormalities before discharge. Results: There were 22 (9.2%) babies with abnormalities in the misoprostol group and 16 (6.2%) abnormalities in controls (p = 0.208). When stratified according to the type of exposure to misoprostol, abnormalities were significantly higher in those with intended exposure than in accidental exposure (12.3 vs 3.5%, p = 0.023). Misoprostol exposure was not significantly associated with abnormalities. Controls were less likely to have abnormalities than those with misoprostol exposure, but this did not remain significant after all cofounders were added to the model. Conclusion: Exposure to misoprostol leads to more congenital abnormalities. However, chances of having a baby with an abnormality are not significantly increased with misoprostol exposure when all other risk factors are controlled for. These findings may aid clinicians in reassuring low-risk women with accidental exposure in early pregnancy. Clinical significance: Women with accidental exposure to misoprostol are less likely to have congenital abnormalities than those with voluntary exposure because they were found to ingest a lesser amount of the drug.