Hemorrhage; Complicating Delivery Clinical Trial
Official title:
Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.
Objective :
To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum
haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.
Method :
Double blinded Randomized controlled trial in two centers over 30 months.
Treatment :
Patients will be randomly allocated into one of the two following group :
Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and
two misoprostol tablets taken orally (400µg) following cord clamp.
Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and
two placebo tablets taken orally following cord clamp.
Number of patients:
1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05
and 0.20 respectively). Patients were included in the study during 48 hours.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention