520
Participants
Start Date
January 6, 2020
Primary Completion Date
July 30, 2022
Study Completion Date
July 30, 2022
Oral misoprostol
"* An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose).~* The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes)~* If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted~* In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency."
Oxytocin
"* Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics.~* The oxytocin group will not receive misoprostol after the membranes have ruptured."
Daga Memorial Women's Hospital, Nagpur
Mahatma Gandhi Institute of Medical Sciences, Sevāgrām
Government Medical College (GMC), Nagpur
Gynuity Health Projects
OTHER
Government Medical College, Nagpur
INDUSTRY
Daga Memorial Women's Hospital, Nagpur, India
OTHER
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India
UNKNOWN
University of Liverpool
OTHER