- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560218
Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT
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
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
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Rajavithi Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Uterotonic agents group A
Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
|
apply drug by Anesthesiologist
|
Experimental: Uterotonic agents group B
Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
|
apply drug by surgeon at uterine cornu
|
No Intervention: Uterotonic agents group C
Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood loss
Time Frame: operation time
|
total blood loss estimated by Anesthesiologist team
|
operation time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin/Hematocrit change
Time Frame: until 24 hours post-operation
|
compare before/after operation
|
until 24 hours post-operation
|
need of uterotonic agents
Time Frame: until 24 hours post-operation
|
number of uterotonic agents need and type of drug
|
until 24 hours post-operation
|
need of blood transfusion
Time Frame: until 24 hours post-operation
|
number of blood transfusion need
|
until 24 hours post-operation
|
adverse drug event
Time Frame: until 24 hours post-operation
|
adverse drug event of Misoprostol and Oxytocin
|
until 24 hours post-operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122/2563
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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