Hafizur Rahman1, Anup Pradhan1, Latha Kharka1, Prachi Renjhen2, Sumit Kar3, Sudip Dutta4. 1. Department of Obstetrics and Gynaecology, Sikkim Manipal Institute of Medical Sciences and associated Central Referral Hospital, Gangtok, Sikkim, India. 2. Department of Obstetrics and Gynaecology, Melaka Manipal Medical College, Melaka, Malaysia. 3. Department of Community Medicine, Sikkim Manipal Institute of Medical Sciences and associated Central Referral Hospital, Gangtok, Sikkim, India. 4. Department of Paediatrics, Sikkim Manipal Institute of Medical Sciences and associated Central Referral Hospital, Gangtok, Sikkim, India.
Abstract
OBJECTIVES: To assess and compare the efficacy and safety of 50 µg oral misoprostol and 25 µg intravaginal misoprostol for induction of labour at term. METHODS: This non-blinded, randomized clinical trial included 228 pregnant women at term with obstetric or medical indications for induction of labour. Women either took 50 µg misoprostol orally (two 25 µg tablets) or had one 25 µg tablet of misoprostol inserted in the posterior vaginal fornix. In each group, misoprostol administration was repeated every four hours in the same dose until regular uterine contractions were established or to a maximum of five doses. Time to delivery and outcome data for each group were compared. RESULTS: Of the 228 women, eight (3.5%) were excluded from the analysis as they withdrew their consent after randomization. Mean induction-to-delivery interval was similar in both groups (21.22 hours in the oral group vs. 20.15 hours in the vaginal group; P = 0.58). There was no significant difference between the groups with respect to the number of women who delivered within 24 hours or who required oxytocin augmentation of labour, the mode of delivery, and neonatal outcomes (P > 0.05). Uterine hyperstimulation occurred in two women who received misoprostol vaginally, but not in any of the women in the oral misoprostol group. CONCLUSION:Oral misoprostol in a dose of 50 µg every four hours, to a maximum of five doses, has the potential to induce labour as safely and effectively as 25 µg misoprostol administered vaginally every four hours.
RCT Entities:
OBJECTIVES: To assess and compare the efficacy and safety of 50 µg oral misoprostol and 25 µg intravaginal misoprostol for induction of labour at term. METHODS: This non-blinded, randomized clinical trial included 228 pregnant women at term with obstetric or medical indications for induction of labour. Women either took 50 µg misoprostol orally (two 25 µg tablets) or had one 25 µg tablet of misoprostol inserted in the posterior vaginal fornix. In each group, misoprostol administration was repeated every four hours in the same dose until regular uterine contractions were established or to a maximum of five doses. Time to delivery and outcome data for each group were compared. RESULTS: Of the 228 women, eight (3.5%) were excluded from the analysis as they withdrew their consent after randomization. Mean induction-to-delivery interval was similar in both groups (21.22 hours in the oral group vs. 20.15 hours in the vaginal group; P = 0.58). There was no significant difference between the groups with respect to the number of women who delivered within 24 hours or who required oxytocin augmentation of labour, the mode of delivery, and neonatal outcomes (P > 0.05). Uterine hyperstimulation occurred in two women who received misoprostol vaginally, but not in any of the women in the oral misoprostol group. CONCLUSION: Oral misoprostol in a dose of 50 µg every four hours, to a maximum of five doses, has the potential to induce labour as safely and effectively as 25 µg misoprostol administered vaginally every four hours.
Entities:
Keywords:
cervical ripening; labour induction; oral misoprostol; prostaglandin; vaginal misoprostol
Authors: P Tsikouras; Z Koukouli; B Manav; M Soilemetzidis; A Liberis; R Csorba; G Trypsianis; G Galazios Journal: Geburtshilfe Frauenheilkd Date: 2016-07 Impact factor: 2.915
Authors: Robbie S Kerr; Nimisha Kumar; Myfanwy J Williams; Anna Cuthbert; Nasreen Aflaifel; David M Haas; Andrew D Weeks Journal: Cochrane Database Syst Rev Date: 2021-06-22