Abstract

To determine effectiveness and safety of sublingual misoprostol in tablets of 25 mcg, given every 6 hours for induction of labor in high-risk pregnant women hospitalized in two teaching hospitals in the Northeast of Brazil. An open, non-randomized clinical trial was conducted, including 40 women with high-risk pregnancies hospitalized at "Maternidade-Escola Assis Chateaubriand" and "Instituto Materno-Infantil de Pernambuco". All of them had gestational age >or= 37 weeks, alive fetus with good vitality and Bishop scores <or= 7. A tablet of 25 mcg of misoprostol was administered every 6 hours, up to a maximum of 4, until active labor. Statistical analysis was performed using the public domain software Epi-Info 3.2.2. Active labor occurred in 100% of cases after misoprostol administration. The mean (+/-SD) induction-to-labor interval was 4.8(+/-3.8 hours. Interval from induction-to-delivery varied from 8 to 31 hours with 95% of the deliveries occurring in the first 24 hours with 75% of vaginal deliveries. The frequency of tachysystole was 12.5%. The women did not present relevant side effects neither were there any neonatal complications. The sublingual tablet of misoprostol of 25 mcg was shown to be effective for induction of labor in high-risk pregnant women. The efficacy and acceptability of this new route should be compared to vaginal administration of misoprostol in future prospective randomized clinical trials.

Highlights

  • The sublingual tablet of misoprostol of 25mcg was shown to be effective for induction of labor in high-risk pregnant women

  • The efficacy and acceptability of this new route should be compared to vaginal administration of misoprostol in future prospective randomized clinical trials. [Rev Assoc Med Bras 2006; 52(4): 251-5]

  • Labor induction with 25mcg versus 50mcg intravaginal misoprostol: A systematic Review

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Summary

NOVA FORMULAÇÃO DE MISOPROSTOL SUBLINGUAL NA INDUÇÃO DO TRABALHO DE PARTO

FRANCISCO EDSON DE LUCENA FEITOSA*, MELANIA MARIA RAMOS DE AMORIM, CARLOS AUGUSTO ALENCAR JÚNIOR, ISABELA CRISTINA COUTINHO, ZULEIKA STUDART SAMPAIO Trabalho realizado na Maternidade-Escola Assis Chateaubriand da Universidade Federal do Ceará e Instituto Materno-Infantil de Pernambuco, Recife, PE. O presente estudo foi realizado com o objetivo de testar a efetividade e segurança do comprimido sublingual de misoprostol, na dose de 25 mcg a cada seis horas, para indução do parto em gestantes de alto risco internadas em dois hospitais-escola do Nordeste do Brasil. Os resultados do presente estudo evidenciam uma elevada efetividade do misoprostol em nova apresentação específica para uso sublingual, com sucesso de 100% para desencadeamento do trabalho de parto, 95% de partos dentro das primeiras 24 horas da indução e 75% de partos por via vaginal, sem efeitos deletérios para o binômio mãe-feto. Mesmo sabendo das limitações metodológicas dos ensaios clínicos abertos, estes resultados corroboram a conclusão de alguns autores de que a dose de 25 mcg é o suficiente para desencadear o trabalho de parto sem, entretanto, aumentar a freqüência de alterações da contratilidade uterina. Conflito de interesse: não há SUMMARY NEW FORMULATION OF SUBLINGUAL MISOPROSTOL (25MCG) FOR

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