International Journal of Infertility & Fetal Medicine

Register      Login

VOLUME 14 , ISSUE 1 ( January-April, 2023 ) > List of Articles


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

Rubina Izhar, Muhammad Ahmad Tahir, Tahir Ghani, Zubaida Masood

Keywords : Abortifacient, Congenital abnormalities, Misoprostol, Unwanted pregnancies

Citation Information : Izhar R, Tahir MA, Ghani T, Masood Z. Comparison of Pregnancy Outcomes between Ongoing Pregnancies after Accidental Misoprostol Use and Normal Pregnancies: A Case-control Study. Int J Infertil Fetal Med 2023; 14 (1):31-37.

DOI: 10.5005/jp-journals-10016-1310

License: CC BY-NC 4.0

Published Online: 28-04-2023

Copyright Statement:  Copyright © 2023; The Author(s).


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.

PDF Share
  1. Chahal H, Mumtaz Z. Abortion and fertility control in Pakistan: the role of misoprostol. J Fam Plann Reprod Health Care 2017;43(4):274–280. DOI: 10.1136/jfprhc-2015-101424
  2. Gonzalez CH, Marques-Dias MJ, Kim CA, et al. Congenital abnormalities in Brazilian children associated with misoprostol misuse in first trimester of pregnancy. Lancet 1998;351(9116):1624–1627. DOI: 10.1016/S0140-6736(97)12363-7
  3. Bos-Thompson MA, Hillaire-Buys D, Roux C, et al. Möbius syndrome in a neonate after mifepristone and misoprostol elective abortion failure. Ann Pharmacother 2008;42(6):888–892. DOI: 10.1345/aph.1K550
  4. Orioli IM, Castilla EE. Epidemiological assessment of misoprostol teratogenicity. BJOG 2000;107(4):519–523. DOI: 10.1111/j.1471- 0528.2000.tb13272.x
  5. Guedes ZC. Möbius syndrome: misoprostol use and speech and language characteristics. Int Arch Otorhinolaryngol 2014;18(3): 239–243. DOI: 10.1055/s-0033-1363466
  6. Pöhls UG, Steck T, Dietl J. Fetal complications after failed pregnancy termination in the first trimester. Z Geburtshilfe Neonatol 2000;204(4):153–157. DOI: 10.1055/s-2000-10213
  7. Auffret M, Bernard-Phalippon N, Dekemp J, et al. Misoprostol exposure during the first trimester of pregnancy: is the malformation risk varying depending on the indication? Eur J Obstet Gynecol Reprod Biol 2016;207:188–192. DOI: 10.1016/j.ejogrb.2016.11.007
  8. Bernard N, Elefant E, Carlier P, et al. Continuation of pregnancy after first-trimester exposure to mifepristone: an observational prospective study. BJOG 2013;120(5):568–574. DOI: 10.1111/1471-0528.12147
  9. Park K. Congenital malformations. In: K Park (Ed). Park's Text book of Preventive and Social Medicine. 15th edition. BANARSIDAS BHANOT PUBLISHERS, 2005; pp. 379–80.
  10. Tayebi N, Yazdani K, Naghshin N. The prevalence of congenital malformations and its correlation with consanguineous marriages. Oman Med J 2010;25(1):37–40. DOI: 10.5001/omj.2010.9
  11. Vendramini-Pittoli S, Guion-Almeida ML, Richieri-Costa A, et al. Clinical findings in children with congenital anomalies and misoprostol intrauterine exposure: a study of 38 cases. J Pediatr Genet 2013;2(4):173–180. DOI: 10.3233/PGE-13066
  12. Andersen JT, Mastrogiannis D, Andersen NL, et al. Diclofenac/misoprostol during early pregnancy and the risk of miscarriage: a Danish nationwide cohort study. Arch Gynecol Obstet 2016;294(2):245–250. DOI: 10.1007/s00404-015-3966-9
  13. Ajao AE, Adeoye IA. Prevalence, risk factors and outcome of congenital anomalies among neonatal admissions in OGBOMOSO, Nigeria. BMC Pediatr 2019;19(1):88. DOI: 10.1186/s12887-019-1471-1
  14. Schüler L, Pastuszak A, Sanseverino TV, et al. Pregnancy outcome after exposure to misoprostol in Brazil: a prospective, controlled study. Reprod Toxicol 1999;13(2):147–151. DOI: 10.1016/s0890-6238(98)00072-0
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.