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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

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

Intervention / Treatment
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* Drug: sublingual Misoprostol
* Drug: Intrauterine Misoprostol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterotonic agents group A<br>Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab | Drug: sublingual Misoprostol<br>* apply drug by Anesthesiologist<br>|
| Experimental: Uterotonic agents group B<br>Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab | Drug: Intrauterine Misoprostol<br>* apply drug by surgeon at uterine cornu<br>|
| No Intervention: Uterotonic agents group C<br>Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | total blood loss estimated by Anesthesiologist team | operation time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin/Hematocrit change | compare before/after operation | until 24 hours post-operation | 
| need of uterotonic agents | number of uterotonic agents need and type of drug | until 24 hours post-operation | 
| need of blood transfusion | number of blood transfusion need | until 24 hours post-operation | 
| adverse drug event | adverse drug event of Misoprostol and Oxytocin | until 24 hours post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Cesarean section, Sublingual Misoprostol, Intrauterine Misoprostol