Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT
Overview
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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: July 31, 2021
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
Interventions
- Drug: sublingual Misoprostol
- apply drug by Anesthesiologist
- Drug: Intrauterine Misoprostol
- apply drug by surgeon at uterine cornu
Arms, Groups and Cohorts
- Experimental: Uterotonic agents group A
- Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
- Experimental: Uterotonic agents group B
- Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
- No Intervention: Uterotonic agents group C
- Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab
Clinical Trial Outcome Measures
Primary Measures
- Blood loss
- Time Frame: operation time
- total blood loss estimated by Anesthesiologist team
Secondary Measures
- Hemoglobin/Hematocrit change
- Time Frame: until 24 hours post-operation
- compare before/after operation
- need of uterotonic agents
- Time Frame: until 24 hours post-operation
- number of uterotonic agents need and type of drug
- need of blood transfusion
- Time Frame: until 24 hours post-operation
- number of blood transfusion need
- adverse drug event
- Time Frame: until 24 hours post-operation
- adverse drug event of Misoprostol and Oxytocin
Participating in This Clinical Trial
Inclusion Criteria
- ≥35 ปี – Previous PPH – Morbid obesity – Fetal macrosomia – Polyhydramnios – Induction/Augmentation of Labour – Prolonged Labour – Grand multiparity – Preeclampsia – Myoma Uteri Exclusion Criteria:
- Asthma – Maternal fever/ Tripple I can't excluded – coagulopathy – Placenta previa/ adherens/ abruptio placenta – Allergy to Prostaglandins/Oxytocin
Gender Eligibility: Female
Pregnant women
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Rajavithi Hospital
- Provider of Information About this Clinical Study
- Sponsor
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