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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterotonic agents group A | Experimental | Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab |
|
| Uterotonic agents group B | Experimental | Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab |
|
| Uterotonic agents group C | No Intervention | Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sublingual Misoprostol | Drug | apply drug by Anesthesiologist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | total blood loss estimated by Anesthesiologist team | operation time |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi hospital | Bangkok | 10400 | Thailand |
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| Intrauterine Misoprostol |
| Drug |
apply drug by surgeon at uterine cornu |
|
| 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 |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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