Iranian Journal of Medical Sciences

Document Type : Original Article(s)

Authors

1 Maternal-Fetal Medicine Research Center, Infertility Research Center, Department of Gynecology and Obstetrics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

2 Student Research Center, Department of Gynecology and Obstetrics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

3 Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

4 Department of Pediatrics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Abstract

Background: We sought to compare the effectiveness and safety of sublingual versus vaginal misoprostol for the termination of pregnancy with a live full-term fetus.Methods: This randomized, triple-blind, placebo-controlled clinical trial was performed on 200 primiparous women with normal, singleton, full-term pregnancies candidated for the induction of labor. Sublingual and vaginal tablets containing misoprostol (25 mcg) or placebo in similar shapes were administered every 4 hours until the Bishop score reached above 8. Maternal and neonatal complications and outcomes were compared.Results: There were 100 parturient women in each group. The mean maternal age, gestational age, and Bishop score at the commencement of misoprostol had no statistical differences between the sublingual and vaginal groups. The mean time interval between misoprostol commencement and delivery was 497.10±291.49 and 511.67±08.46 minutes for the sublingual and vaginal groups, correspondingly. Twenty-two women had Cesarean deliveries in the sublingual group versus 14 in the vaginal group. Meconium-stained amniotic fluid was seen in 12 women in the sublingual group and 4 in the vaginal group (P=0.03). Late fetal heart rate deceleration was observed in 8 women in the sublingual group and 4 in the vaginal group (P=0.22). The mean neonatal birth weight, blood gas value at birth, Apgar score, and length of admission time in the neonatal intensive care unit were not different between the 2 groups.Conclusion: Sublingual and vaginal misoprostol had similar effectiveness; however, meconium-stained liquor was observed considerably more frequently with sublingual misoprostol than with vaginal misoprostol.Trial Registration Number: IRCT201402096541N3

Keywords

  1. Biringer A, Lee L, Dy J, Leduc D. Induction of labour. Canada: The Society of Obstetricians and Gynecologists of Canada; 2001.
  2. Hofmeyr GJ, Gülmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour (review). London: Cochrane Database Syst Rev; 2010.
  3. Senior J, Marshall K, Sangha R, Clayton JK. In vitro characterization of prostanoid receptors on human myometrium at term pregnancy. Br J Pharmacol. 1993;108:501‑6. doi: 10.1111/j.1476-5381.1993.tb12832.x. PubMed PMID: 8448599; PubMed Central PMCID: PMC1908003.
  4. Margulies M, Campos Perez G, Voto LS. Misoprostol to induce labour. Lancet. 1992;339:64. doi: 10.1016/0140-6736(92)90194-8. PubMed PMID: 1345991.
  5. Induction of labour. London: NICE Clinical guideline 70; 2008.
  6. Obstetrics ACoPB--. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009;114:386-97. doi: 10.1097/AOG.0b013e3181b48ef5. PubMed PMID: 19623003.
  7. Rayburn WF, Zhang J. Rising rates of labor induction: present concerns and future strategies. Obstet Gynecol. 2002;100:164‑7. doi: 10.1016/S0029-7844(02)02047-1. PubMed PMID: 12100818.
  8. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S. Births: final data for 2004. Natl Vital Stat Rep. 2006;55:1-101. PubMed PMID: 17051727.
  9. Caughey AB, Sundaram V, Kaimal AJ, Gienger A, Cheng YW, McDonald KM, et al. Systematic review: elective induction of labor versus expectant management of pregnancy. Ann Intern Med. 2009;151:252‑63, W53-63. doi: 10.7326/0003-4819-151-4-200908180-00007. PubMed PMID: 19687492.
  10. Alfirevic Z, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2006:CD001338. doi: 10.1002/14651858.CD001338.pub2. PubMed PMID: 16625542.
  11. Aronsson A, Bygdeman M, Gemzell-Danielsson K. Effects of misoprostol on uterine contractility following different routes of administration. Hum Reprod. 2004;19:81‑4. doi: 10.1093/humrep/deh005. PubMed PMID: 14688161.
  12. Caliskan E, Bodur H, Ozeren S, Corakci A, Ozkan S, Yucesoy I. Misoprostol 50 μg sublingually versus vaginally for labor induction at term: a randomized study. Gynecologic and obstetric investigation. 2005;59:155-61.
  13. Feitosa FE, Sampaio ZS, Alencar CA, Jr., Amorim MM, Passini R, Jr. Sublingual vs. vaginal misoprostol for induction of labor. Int J Gynaecol Obstet. 2006;94:91-5. doi: 10.1016/j.ijgo.2006.04.031. PubMed PMID: 16828095.
  14. Souza AS, Amorim MM, Feitosa FE. Comparison of sublingual versus vaginal misoprostol for the induction of labour: a systematic review. BJOG. 2008;115:1340‑9. doi: 10.1111/j.1471-0528.2008.01872.x. PubMed PMID: 18823486.
  15. Moraes Filho OBd, Albuquerque RMd, Pacheco ÁJC, Ribeiro RH, Cecatti JG, Welkovic S. Sublingual versus vaginal misoprostol for labor induction of term pregnancies. Rev Bras Ginecol Obstet. 2005;27:24-31.
  16. Zahran KM, Shahin AY, Abdellah MS, Elsayh KI. Sublingual versus vaginal misoprostol for induction of labor at term: a randomized prospective placebo-controlled study. J Obstet Gynaecol Res. 2009;35:1054‑60. doi: 10.1111/j.1447-0756.2009.01030.x. PubMed PMID: 20144171.
  17. Crane JM, Young DC, Butt KD, Bennett KA, Hutchens D. Excessive uterine activity accompanying induced labor. Obstet Gynecol. 2001;97:926-31. doi: 10.1016/S0029-7844(01)01332-1. PubMed PMID: 11384698.
  18. Nassar AH, Awwad J, Khalil AM, Abu-Musa A, Mehio G, Usta IM. A randomised comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labour at term. BJOG. 2007;114:1215-21. doi: 10.1111/j.1471-0528.2007.01492.x. PubMed PMID: 17877674.
  19. Mousa HA, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev. 2007:CD003249. doi: 10.1002/14651858.CD003249.pub2. PubMed PMID: 17253486.
  20. Misoprostol Recommended Dosages [Internet]. London: International Federation of Gynecology and Obstetrics. c2012. Available from: http://www.figo.org/sites/default/files/uploads/project-publications/Miso/Misoprostol_Recommended%20Dosages%202012.pdf.
  21. Misoprostol dosage guidelines [Internet]. United Kingdom: Misoprostol. c2012. Available from: http://www.misoprostol.org/dosage-guidelines.
  22. Misoprostol dosage guidelines [Internet]. United Kingdom: Misoprostol. c2012. Available from: http://www.misoprostol.org/dosage-guidelines.