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

  • Maternal-Fetal Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

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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References

  1. Maul H, Mackay L, Garfield RE (2006) Cervical ripening: biochemical, molecular, and clinical considerations. Clin Obstet Gynecol 49:551

    Article  PubMed  Google Scholar 

  2. Word RA, Li XH, Hnat M, Carrick K (2007) Dynamics of cervical remodeling during pregnancy and parturition: mechanisms and current concepts. Semin Reprod Med 25:69

    Article  CAS  PubMed  Google Scholar 

  3. Timmons BC, Mahendroo M (2007) Processes regulating cervical ripening differ from cervical dilation and postpartum repair: insights from gene expression studies. Reprod Sci 14:53

    Article  CAS  PubMed  Google Scholar 

  4. Keirse MJ (2006) Natural prostaglandins for induction of labor and preinduction cervical ripening. Clin Obstet Gynecol 49:609

    Article  PubMed  Google Scholar 

  5. Vaknin Z, Kurzweil Y, Sherman D (2010) Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol 203:418

    Article  PubMed  Google Scholar 

  6. ACOG Committee on Practice Bulletins (2009) Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol 114:386

    Article  Google Scholar 

  7. Keirse MJ (1993) Prostaglandins in preinduction cervical ripening. Meta-analysis of worldwide clinical experience. J Reprod Med 38:89

    CAS  PubMed  Google Scholar 

  8. Prins RP, Neilson DR Jr, Bolton RN et al (1986) Preinduction cervical ripening with sequential use of prostaglandin E2 gel. Am J Obstet Gynecol 154:1275

    Article  CAS  PubMed  Google Scholar 

  9. Farah LA, Sanchez-Ramos L, Rosa C et al (1997) Randomized trial of two doses of the prostaglandin E1 analog misoprostol for labor induction. Am J Obstet Gynecol 177:364

    Article  CAS  PubMed  Google Scholar 

  10. Wing DA, Park MR, Paul RH (2000) A randomized comparison of oral and intravaginal misoprostol for labor induction. Obstet Gynecol 95:905

    CAS  PubMed  Google Scholar 

  11. Wolf SB, Sanchez-Ramos L, Kaunitz AM (2005) Sublingual misoprostol for labor induction: a randomized clinical trial. Obstet Gynecol 105:365

    Article  CAS  PubMed  Google Scholar 

  12. Tang OS, Schweer H, Seyberth HW et al (2002) Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod 17:332

    Article  CAS  PubMed  Google Scholar 

  13. Alfirevic Z, Aflaifel N, Weeks A (2014) Oral misoprostol for induction of labour. Cochrane Database Syst Rev 6:CD001338

    Google Scholar 

  14. Hofmeyr GJ, Gülmezoglu AM, Pileggi C (2010) Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. doi:10.1002/14651858.CD000941

    PubMed Central  Google Scholar 

  15. Austin SC, Sanchez-Ramos L, Adair CD (2010) Labor induction with intravaginal misoprostol compared with the dinoprostone vaginal insert: a systematic review and metaanalysis. Am J Obstet Gynecol 202:624.e1

    Article  CAS  Google Scholar 

  16. Sharami SH, Milani F, Faraji R, Bloukimoghadam K, Salamat F, Momenzadeh S, Ebrahimi H (2014) Comparison of 25 μg sublingual and 50 μg intravaginal misoprostol for cervical ripening and labor: a randomized controlled equivalence trial. Arch Iran Med 17(10):652–656

    PubMed  Google Scholar 

  17. Nassar AH, Awwad J, Khalil AM, Abu-Musa A, Mehio G, Usta IM (2007) A randomized comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labour at term. BJOG 114:1215–1221

    Article  CAS  PubMed  Google Scholar 

  18. Zahran K, Shahin A, Abdellah M, Elsayh K (2009) Sublingual versus vaginal misoprostol for induction of labor at term: a randomized prospective placebo-controlled study. J Obstet Gynaecol Res 35(6):1054–1060

    Article  CAS  PubMed  Google Scholar 

  19. Caliskan E, Bodur H, Ozeren S, Corakci A, Ozkan S, Yucesoy I (2005) Misoprostol 50 mg sublingually versus vaginally for labour induction at term. Gynecol Obstet Invest 59:155–156

    Article  CAS  PubMed  Google Scholar 

  20. Feitosa FEL, Sampaio ZS, Alencar CA Jr, Amorim MMR, Passini R Jr (2006) Sublingual versus vaginal misoprostol for induction of labour. Int J Gynaecol Obstet 94:91–95

    Article  CAS  PubMed  Google Scholar 

  21. Carlan SJ, Blust D, O’Brien WF (2002) Buccal versus intravaginal misoprostol administration for cervical ripening. Am J Obstet Gynecol 186(2):229–233

    Article  CAS  PubMed  Google Scholar 

  22. Mizrachi Y, Levy M, Bar J, Kovo M (2016) Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet 294(4):725–730. doi:10.1007/s00404-016-4026-9

    Article  CAS  PubMed  Google Scholar 

  23. Ezechukwu PC, Ugwu EO, Obi SN, Chigbu CO (2015) Oral versus vaginal misoprostol for induction of labor in Enugu, Nigeria: a randomized controlled trial. Arch Gynecol Obstet 291(3):537–544. doi:10.1007/s00404-014-3429-8

    Article  PubMed  Google Scholar 

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Authors and 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.

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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

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