Andrés Conde1,2, Sebastián Ben3, Josefina Tarigo3, Santiago Artucio3, Virginia Varela3, Pamela Grimaldi3, Claudio Sosa3, Justo Alonso3. 1. Department of Obstetrics and Ginecology, Hospital Pereira Rossell, University of Uruguay, Bulevar Gral, Artigas 1550, Montevideo, 11600, Uruguay. acmaine@hotmail.com. 2. , Gabriel Pereira 2845, CP 11300, Montevideo, Uruguay. acmaine@hotmail.com. 3. Department of Obstetrics and Ginecology, Hospital Pereira Rossell, University of Uruguay, Bulevar Gral, Artigas 1550, Montevideo, 11600, Uruguay.
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 withmisoprostol. 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 receivedsublingual 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/ .
RCT Entities:
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/ .
Authors: Daniele S M B Gattás; Melania M R de Amorim; Francisco E L Feitosa; José R da Silva-Junior; Lívia C G Ribeiro; Gustavo F A Souza; Alex S R Souza Journal: Reprod Health Date: 2020-04-10 Impact factor: 3.223