Carbetocin Compared To Oxytocin During Cesarean Delivery

Study Overview
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Brief Summary
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As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Detailed Description
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Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Official Title
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Undesired Effects of Carbetocin Compared To Oxytocin Administered As Single Intravenous Dose or Infusion During Cesarean Delivery: A Prospective Randomised Controlled Study

Conditions
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Cesarean Delivery

Intervention / Treatment
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* Drug: oxytocin
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal singleton pregnancy at gestational age of 36 weeks or more. Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension) pregnancy after in vitro fertilization Exclusion Criteria: placenta praevia or invasive placenta. pre-eclampsia. Bleeding disorder, such as von Willebrand disease type I. Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin). Any known intolerance to either of the study drugs. Prolonged QT-time. Other serious cardiac disease. Liver or kidney failure.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oxytocin group<br>Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection. | Drug: oxytocin<br>* Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders<br>* Other names: Syntocinon;|
| Carbetocin group<br>Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection. | Drug: Carbetocin<br>* Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders<br>* Other names: Pabal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial effects | Electrocardiograph (QT interval) | immediately before drug administration | 
| Myocardial effects | Electrocardiograph (QT interval) | 24 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac enzyme | Troponin | immediately before drug administration | 
| Cardiac enzyme | Troponin | 24 hours after drug administration | 
| Uterine contraction | Palpate the fundus throughout a contraction to determine intensity | One hour post delivery |