To Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk Women
Conditions
Keywords
Postpartum hemorrhage, Cesarean section, Sublingual Misoprostol, Intrauterine Misoprostol
Brief 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
Interventions
apply drug by Anesthesiologist
apply drug by surgeon at uterine cornu
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | operation time | total blood loss estimated by Anesthesiologist team |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin/Hematocrit change | until 24 hours post-operation | compare before/after operation |
| need of uterotonic agents | until 24 hours post-operation | number of uterotonic agents need and type of drug |
| need of blood transfusion | until 24 hours post-operation | number of blood transfusion need |
| adverse drug event | until 24 hours post-operation | adverse drug event of Misoprostol and Oxytocin |
Countries
Thailand
Outcome results
None listed