- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053922
The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)
February 5, 2014 updated by: karim H abdel-maeboud, Ain Shams University
The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section
The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section.
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Phase 3
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
-
-
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Cairo, Egypt
- Ain Shams Maternity Hospital
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-
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 to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 18 years or more.
- Gestational age of pregnancy of 37 completed weeks or more.
- Written and signed informed consent by the patient to participate in the study.
Exclusion Criteria:
- fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
- Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
- Women planned to have any other type of uterine incision other than transverse lower segment.
- Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
- Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women.
- Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
- Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
- Women with history of hypersensitivity to oxytocin or carbetocin.
- Women with any severe allergic condition or severe asthma.
- Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
- Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Syntocinon
Drug is given just after delivery of the neonate during cesarean section.
|
Syntocinon ampoules (10 IU Oxytocin).
(Novartis Pharma, Egypt) One ampoule 10 IU diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS, followed by an intravenous drip of 20 IU oxytocin in 500 ml saline over 4 hours.
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Active Comparator: Carbetocin
Drug is given just after delivery of the neonate during cesarean section.
|
Carbetocin (Ampoule 100 μg/ml) .
[Pabal, Marketing Authorization Holder: Ferring GmbH (Gesellschaft mit beschränkter Haftung), Kiel ,Germany.
Manufactured by DRAXIS Pharma , a division of specialty Pharmaceuticals Inc. Montreal ,Canada] ,diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS.
Other Names:
|
Active Comparator: Misoprostol
Drug is given just after delivery of the neonate during cesarean section.
|
Misoprostol (200 mcg Tablet) [Misotac, Sigma Pharmaceutical Industries, SAE, Egypt] Two tablets (400 mcg) in the buccal space just after delivery of the neonate during CS.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section
Time Frame: an expected average 1 week
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an expected average 1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events recorded during the study.
Time Frame: an expected average 1 week
|
an expected average 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karim H Abd-El-Maeboud, MD, Ain Shams University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 27, 2013
First Submitted That Met QC Criteria
February 3, 2014
First Posted (Estimate)
February 4, 2014
Study Record Updates
Last Update Posted (Estimate)
February 6, 2014
Last Update Submitted That Met QC Criteria
February 5, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Pregnancy Complications
- Obstetric Labor Complications
- Puerperal Disorders
- Uterine Hemorrhage
- Hemorrhage
- Postpartum Hemorrhage
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Reproductive Control Agents
- Anti-Ulcer Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Oxytocin
- Misoprostol
- Carbetocin
Other Study ID Numbers
- OCMCS
- ASU maternity Hospital (Registry Identifier: ASU maternity Hospital)
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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