Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients Undergoing Caesarean Section

Study Overview
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Brief Summary
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Postpartum hemorrhage (PPH) is the primary cause of nearly one quarter of all maternal deaths globally. Management of uterine tone after delivery involves giving a prophylactic uterotonic and the use of controlled cord traction to facilitate delivery of the placenta and minimize blood loss. Syntocinon and carbetocin are the most commonly used drugs ,During caesarean delivery of stenotic valvular disease patient, the anesthesiologist have an important question: what is the best drug used for prevention of PPH with minimal hemodynamic effect regarding Systemic vascular resistance (SVR), Cardiac out put (COP),Heart rate ( HR), blood pressure? As uterotonic drugs may cause severe hypotension, decrease in SVR and COP that may not be tolerated by these patients .this thesis aims to compare between syntocinon and carbetocin regarding their effect on cardiac output and systemic vascular resistance using cardiometry in cardiac patients with stenotic lesions during caesarean delivery.

Official Title
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Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients With Stenotic Valvular Heart Disease Undergoing Caesarean Section

Conditions
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Adverse Effect of Oxytocic Drugs

Intervention / Treatment
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* Drug: Syntocinon
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant female single tone >38 weeks Age :18-45 years old. patient with ASA III Cardiac patients ( mild and moderate mitral stenosis-aortic stenosis valve disease ) Exclusion Criteria: Other cardiac conditions (valve regurge, cardiomyopathy, heart failure,severe mitral stenosis, severe aortic stenosis, severe pulmonary hypertension) Pregnancy hypertensive disorders (eclampsia,preeclampsia) Abnormal placental attachment (accrete,percreta,increta) Patients with bleeding disorders patient with high risk of postpartum haemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: syntocinon group<br>in this group :5 mL syringe containing a bolus of 1 IU of oxytocin and infusion syringe which will be prepared with a 50 mL syringe containing 0.4 IU/mL of oxytocin and infusion rate of 7.5 IU/h will be administrated to the patient after delivery of the fetus shoulder, Additional bolus syringes will be prepared for use as rescue boluses if needed  which will be 5 ml syringe containing 3 IU of oxytocin | Drug: Syntocinon<br>* uterotonic drugs<br>|
| Active Comparator: carbetocin group<br>in this group :5 mL syringe containing a bolus of 100 mcg of carbetocin and infusion syringe  which will be prepared with a 50 mL syringe containing normal saline will be administrated for the patient after delivery of the fetus shoulder. Additional bolus syringes will be prepared for use as rescue boluses if needed which will be 5 ml syringe containing 100 mcg of carbetocin | Drug: Carbetocin<br>* uterotonic drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | Average Cardiac output after study drug administration | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic vascular resistance | Systemic vascular resistance every 2 minute till end of surgery | intraoperative |