Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT
NCT ID: NCT04560218
Last Updated: 2021-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2020-10-30
2021-09-10
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Uterotonic agents group A
Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
sublingual Misoprostol
apply drug by Anesthesiologist
Uterotonic agents group B
Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
Intrauterine Misoprostol
apply drug by surgeon at uterine cornu
Uterotonic agents group C
Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab
No interventions assigned to this group
Interventions
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sublingual Misoprostol
apply drug by Anesthesiologist
Intrauterine Misoprostol
apply drug by surgeon at uterine cornu
Eligibility Criteria
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Inclusion Criteria
* Previous PPH
* Morbid obesity
* Fetal macrosomia
* Polyhydramnios
* Induction/Augmentation of Labour
* Prolonged Labour
* Grand multiparity
* Preeclampsia
* Myoma Uteri
Exclusion Criteria
* Maternal fever/ Tripple I can't excluded
* coagulopathy
* Placenta previa/ adherens/ abruptio placenta
* Allergy to Prostaglandins/Oxytocin
FEMALE
Yes
Sponsors
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Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
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Locations
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Rajavithi hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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122/2563
Identifier Type: -
Identifier Source: org_study_id
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