NCT04560218

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

Sublingual Versus Intrauterine MISOPROSTOL in Addition to Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Randomized Placebo Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Detailed description

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

Conditions

• To Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk Women

Interventions

Type	Name	Description
DRUG	sublingual Misoprostol	apply drug by Anesthesiologist
DRUG	Intrauterine Misoprostol	apply drug by surgeon at uterine cornu

Timeline

• Start date: 2020-10-30
• Primary completion: 2021-07-31
• Completion: 2021-09-10
• First posted: 2020-09-23
• Last updated: 2021-09-13

Locations

1 site across 1 country: Thailand