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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,721
two misoprostol tablets taken orally (400µg)
Chi Poissy St Germain
Poissy, France
Occurrence of post partum hemorrhage > 500mL in 1 hour
Time frame: 1 HOUR
Occurrence of post partum hemorrhage > 1000mL in 1 hour
Time frame: 1 HOUR
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