Research Objective: Primary outcome -To compare efficacy Intrauterine vs Sublingual MISOPROSTOL in addition to Oxytocin in reducing blood loss of post-cesarean section in high risk women Secondary outcome -To study Hemoglobin/Hematocrit change, need of uterotonic agents, need of blood transfusion, adverse drug event of Intrauterine vs Sublingual Misoprostol plus Oxytocin compare to Oxytocin alone Hypothesis: -Intrauterine MISOPROSTOL plus Oxytocin is not inferior to Sublingual MISOPROSTOL plus Oxytocin in reducing blood loss of post-cesarean section in high risk women
Research Design: Double-blind Randomized Placebo Controlled Trial Subject: Singleton pregnancy GA 34 wk or more with high risk for postpartum hemorrhage undergo cesarean section with spinal anesthesia in Rajavithi Hospital Allocated to 3 groups * group1: Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab * group2: Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab * group3: Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
135
apply drug by Anesthesiologist
apply drug by surgeon at uterine cornu
Rajavithi hospital
Bangkok, Thailand
Blood loss
total blood loss estimated by Anesthesiologist team
Time frame: operation time
Hemoglobin/Hematocrit change
compare before/after operation
Time frame: until 24 hours post-operation
need of uterotonic agents
number of uterotonic agents need and type of drug
Time frame: until 24 hours post-operation
need of blood transfusion
number of blood transfusion need
Time frame: until 24 hours post-operation
adverse drug event
adverse drug event of Misoprostol and Oxytocin
Time frame: until 24 hours post-operation
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