OBJECTIVE: To select the misoprostol dose to be used in a large multicentre randomised trial comparing misoprostol with oxytocin in the routine management of the third stage of labour. DESIGN: Randomised pilot trial, double-blinded with the use of double placebos. SETTING: Two of the nine hospitals that will participate in the main multicentre trial. The hospitals were located in Johannesburg, South Africa and Khon Kaen, Thailand. POPULATION: Women during second stage of labour about to be delivered vaginally. METHODS: The trial had three arms: misoprostol 400 microg versus misoprostol 600 microg versus intramuscular oxytocin 10 IU. Each group received an injection and three tablets immediately after the birth of the baby. MAIN OUTCOME MEASURES: Shivering and pyrexia rates were the main outcome measures. Data on other side effects and characteristics of the third stage of labour were also collected. Side effects were noted as none, mild, moderate or severe. RESULTS: Both shivering and pyrexia (temperature > 38 degrees C) were most common in the 600 microg misoprostol group (28% and 7.5% for shivering and pyrexia, respectively) compared with 400 microg misoprostol (19% and 2%), and the oxytocin group (12.5% and 3%). The increase in shivering in the misoprostol 600 microg group was due primarily to a higher rate of moderate shivering. None of the women had a temperature > 40 degrees C. There were no increases in severe side effects and other adverse events in the misoprostol 600 microg group. CONCLUSIONS: When used in the management of the third stage of labour oral misoprostol is associated with an increase in the rate of moderate shivering and pyrexia which seems to be dose-related. Based on the results of this pilot trial, the Steering Committee has decided to use 600 microg misoprostol in the main trial, comparing it with oxytocin, in order to achieve higher effectiveness.
RCT Entities:
OBJECTIVE: To select the misoprostol dose to be used in a large multicentre randomised trial comparing misoprostol with oxytocin in the routine management of the third stage of labour. DESIGN: Randomised pilot trial, double-blinded with the use of double placebos. SETTING: Two of the nine hospitals that will participate in the main multicentre trial. The hospitals were located in Johannesburg, South Africa and Khon Kaen, Thailand. POPULATION: Women during second stage of labour about to be delivered vaginally. METHODS: The trial had three arms: misoprostol 400 microg versus misoprostol 600 microg versus intramuscular oxytocin 10 IU. Each group received an injection and three tablets immediately after the birth of the baby. MAIN OUTCOME MEASURES: Shivering and pyrexia rates were the main outcome measures. Data on other side effects and characteristics of the third stage of labour were also collected. Side effects were noted as none, mild, moderate or severe. RESULTS: Both shivering and pyrexia (temperature > 38 degrees C) were most common in the 600 microg misoprostol group (28% and 7.5% for shivering and pyrexia, respectively) compared with 400 microg misoprostol (19% and 2%), and the oxytocin group (12.5% and 3%). The increase in shivering in the misoprostol 600 microg group was due primarily to a higher rate of moderate shivering. None of the women had a temperature > 40 degrees C. There were no increases in severe side effects and other adverse events in the misoprostol 600 microg group. CONCLUSIONS: When used in the management of the third stage of labour oral misoprostol is associated with an increase in the rate of moderate shivering and pyrexia which seems to be dose-related. Based on the results of this pilot trial, the Steering Committee has decided to use 600 microg misoprostol in the main trial, comparing it with oxytocin, in order to achieve higher effectiveness.
Authors: G Justus Hofmeyr; A Metin Gülmezoglu; Natalia Novikova; Verena Linder; Sandra Ferreira; Gilda Piaggio Journal: Bull World Health Organ Date: 2009-09 Impact factor: 9.408
Authors: Suellen Miller; Carrie Tudor; Vanessa Thorsten; Karma Quzong; Tsering Dekyi; Ty Hartwell; Linda L Wright; Michael W Varner Journal: J Midwifery Womens Health Date: 2009 Mar-Apr Impact factor: 2.388
Authors: Ioannis D Gallos; Helen M Williams; Malcolm J Price; Abi Merriel; Harold Gee; David Lissauer; Vidhya Moorthy; Aurelio Tobias; Jonathan J Deeks; Mariana Widmer; Özge Tunçalp; Ahmet Metin Gülmezoglu; G Justus Hofmeyr; Arri Coomarasamy Journal: Cochrane Database Syst Rev Date: 2018-04-25
Authors: Gilda Piaggio; Diana Elbourne; Kenneth F Schulz; José Villar; Alain P Y Pinol; A Metin Gülmezoglu Journal: BMC Med Res Methodol Date: 2003-10-03 Impact factor: 4.615