- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578263
Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage
August 3, 2020 updated by: hany farouk, Aswan University Hospital
Carbetocin Versus Oxytocin and Ergometrine for Prevention of Postpartum Hemorrhage Following a Cesarean Section in Women With Multiple Gestation
The cesarean section is a bloody operation, about 750 to 1000 ml are lost at most operations and over 1000 ml of blood have lost to bring them into the definition of a postpartum hemorrhage (PPH).
In developing countries, PPH is the main cause of maternal deaths.
Uterine atony is the most common cause of immediate heavy PPH.Multiple pregnancy ones of a common factor for uterine atony.
The administration of oxytocic's after the delivery of the neonate reduces the likelihood of PPH and 5 IU oxytocin by slow intravenous injection is currently recommended for all cesarean sections.
However, the use of additional oxytocic medication is common, to arrest bleeding, or prophylactically if there are risk factors for PPH .
Carbetocin is a synthetic analog of human oxytocin with structural modifications that increase its half-life, thereby prolonging its pharmacological effects.
Carbetocin has been approved in 23 countries for prevention of uterine atony and excessive bleeding following cesarean delivery in spinal or epidural anesthesia.
Oxytocin is a peptide of nine amino acids (Nona peptide).
The structure of oxytocin is very similar to that of arginine vasopressin, whose sequence differs from oxytocin by 2 amino acids.
The best-known mechanism for oxytocin to exert its stimulatory effect on myometrial contractility is by increasing the intracellular concentration of calcium.
Owing to its short plasma half-life (mean 3 min), a continuous intravenous infusion is required to maintain the uterus in a contracted state.
The usual dose is 20 IU in 500 ml of crystalloid solution, with the dosage rate adjusted according to response.
Ergometrine is a selective and moderately potent tryptaminergic receptor antagonist in various smooth muscles, being only a partially agonistic or antagonistic at tryptaminergic receptors in the central nervous system.
In blood vessels, the alkaloid is only weakly antagonistic of dopaminergic receptors and partially agonistic of α-adrenergic receptors.
oxytocin (19%).
Blood loss>500 ml was only observed in women who received oxytocin.
The aim of the investigator's study was to compare the effect of carbetocin vs. oxytocin and ergometrine for prevention of PPH during cesarean section in women with multiple pregnancies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Women included in the study were divided into 2 groups: Group (A): included patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby.
Group (B): included patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg.
The slow administration has been shown to reduce the potentially harmful hemodynamic effects of oxytocin (and presumably carbetocin).
Also, intramuscular injection of ergometrine did the same.
All women were subjected to full history taking, general and obstetric examination and investigations in the form of preoperative routine labs and obstetric ultrasound, and postoperative serum hemoglobin %.
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Not Applicable
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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Aswan, Egypt, 81528
- AswanUH
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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 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women with a multiple term pregnancy undergoing elective cesarean section
Exclusion Criteria:
- single gestation
- placenta praevia and placental abruption
- undergoing cesarean section with general anesthesia
- women undergoing cesarean section at less than 37 weeks of gestation
- with a severe medical disorder
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: carbetocin arm
carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby
|
Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby.
Other Names:
|
Active Comparator: oxytocin and ergometrine arm
oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist plus intramuscular ergometrine 0.2 mg after the birth of the baby
|
Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and
Other Names:
intramuscular ergometrine 0.2 mg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
estimation of intraoperative blood loss (ml).
Time Frame: intraoperative
|
Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.).
Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain.
After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and
vaginal bleeding
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intraoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
need for blood transfusion
Time Frame: 24 hours postoperative
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need for blood transfusion
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24 hours postoperative
|
Hemoglobin concentration
Time Frame: ist 24 hours postoperative]
|
pre and postoperative hemoglobin estimation
|
ist 24 hours postoperative]
|
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)
April 1, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
May 14, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 6, 2018
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 3, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aswu/204/2/18
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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