- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089176
Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH
September 11, 2019 updated by: Rajavithi Hospital
Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial
Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Randomized controlled clinical trial.
Defined patient in two group.
Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Rajavithi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- previous history of postpartum hemorrhage
- polyhydramnios
- fetal macrosomia
- previous cesarean section
- grand multiparity
- intramural myoma
- chorioamnionitis
- prolonged premature rupture of membrane
- augmentation of labour
Exclusion Criteria:
- pregnancy induce hypertension
- on anticoagulant
- placenta previa or placenta percreta
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: protocal A
Carbetocin versus placebo
|
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr
|
Active Comparator: protocal B
Oxytocin versus placebo
|
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional drug use
Time Frame: during intra-operation
|
Number of additional drug use after intervention drug
|
during intra-operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimate blood loss
Time Frame: During intra-opeartion and acute post operation period as 24 hours post operation
|
amount of blood loss
|
During intra-opeartion and acute post operation period as 24 hours post operation
|
Side effect
Time Frame: During intra-opeartion and acute post operation period as 24 hours post operation
|
type of side effect
|
During intra-opeartion and acute post operation period as 24 hours post operation
|
Hemoglobin level
Time Frame: Pre-operation and 24 hours post operation
|
differentiation of hemoglobin
|
Pre-operation and 24 hours post operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
April 28, 2019
First Submitted That Met QC Criteria
September 11, 2019
First Posted (Actual)
September 13, 2019
Study Record Updates
Last Update Posted (Actual)
September 13, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T.Sopida
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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