drugset / Trial / NCT04560218

Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT

NCT04560218

RandomizedParallel-groupQuadruple-blindPrevention

Summary

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

Timeline

Start
2020-10-30
Primary completion
2021-07-31
Completion
2021-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 0.4 mg Other

Indications

No indication recorded.