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Comparison between vaginal and sublingual misoprostol 50 µg for cervical ripening prior to induction of labor: randomized clinical trial

Archives of Gynecology and Obstetrics volume 295, pages 839–844 (2017)Cite this article

Abstract

Objective

To compare the effectiveness and safety of sublingual versus vaginal misoprostol on improving the Bishop score after 6 h of administration.

Methods

Randomized clinical trial which includes pregnant women in gestational ages from 32/0 to 41/6, with indication of induction of labor with misoprostol. Bishop score was assessed at the time of induction and 6 h after administration of 50 µg misoprostol. Analysis was made over difference in mean Bishop score of 2 points, using a standard deviation of 2, with 90% power, reaching a 95% confidence interval.

Results

102 patients were studied, 51 received sublingual misoprostol, and 51 received vaginal misoprostol. There was a statistically significant difference in cervical modifications in global terms regardless of the administration route at 6 h (P < 0.05). When analyzing each group, there was no significant difference for the mean and standard deviation for Bishop score for sublingual and vaginal route (P = 0.761). There was no significant difference in terms of mode of delivery, Apgar score, cord pH, nor in the presence of complications.

Conclusion

There is no statistically significant difference in terms of administration route for cervical ripening using misoprostol 50 µg, whether it was sublingual or vaginal.

Trial registration number

NCT02732522.

Registry website: https://clinicaltrials.gov/.

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Affiliations

  1. Department of Obstetrics and Ginecology, Hospital Pereira Rossell, University of Uruguay, Bulevar Gral, Artigas 1550, Montevideo, 11600, Uruguay

    Andrés Conde, Sebastián Ben, Josefina Tarigo, Santiago Artucio, Virginia Varela, Pamela Grimaldi, Claudio Sosa & Justo Alonso

  2. Gabriel Pereira 2845, CP 11300, Montevideo, Uruguay

    Andrés Conde

Authors
  1. Andrés Conde
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  2. Sebastián Ben
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  3. Josefina Tarigo
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  4. Santiago Artucio
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  5. Virginia Varela
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  6. Pamela Grimaldi
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  7. Claudio Sosa
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  8. Justo Alonso
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Contributions

Author contribution statement

A Conde Project development, manuscript writing, manuscript editing, data analysis. S Ben Project development, data analysis. P Grimaldi Data collection. Administrative technical or material support. S Artucio Data collection, manuscript editing. V Varela: Data collection. J Tarigo: Data collection. Administrative technical or material support. C Sosa: Critical revision of the manuscript for important intellectual content. J Alonso: Critical revision of the manuscript for important intellectual content.

Corresponding author

Correspondence to Andrés Conde.

Ethics declarations

Conflict of interest

Author A Conde declares that he has no conflict of interest. Author S Ben declares that he has no conflict of interest. Author P Grimaldi that she has no conflict of interest. Author V Varela declares that she has no conflict of interest. Author J Tarigo declares that she has no conflict of interest. Author S Artucio declares that he has no conflict of interest. Author C Sosa declares that he has no conflict of interest. Author J Alonso declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

The authors have no financial relationships related research. Authors state that they have had full control of all primary data and they agree to allow the Journal to review their data if requested.

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Conde, A., Ben, S., Tarigo, J. et al. Comparison between vaginal and sublingual misoprostol 50 µg for cervical ripening prior to induction of labor: randomized clinical trial. Arch Gynecol Obstet 295, 839–844 (2017). https://doi.org/10.1007/s00404-017-4297-9

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  • DOI: https://doi.org/10.1007/s00404-017-4297-9

Keywords

  • Cervical ripening
  • Misoprostol
  • Sublingual