Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

Study Overview
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Brief Summary
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A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013. The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS). Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.

Detailed Description
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OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate (HR), saturation of oxygen (SpO2) in certain time after drug injection. The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves. Hemoglobin and troponin-T level The need for additional oxytocin infusion and estimated blood loss The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened.

Official Title
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Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial

Conditions
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Pregnancy Related, Anaesthesia

Intervention / Treatment
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* Drug: Carbetocin
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS. Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby. Ability to provide informed consent. Exclusion Criteria: Emergency caesarean section Preterm Labour Grandmultipara Multiple Pregnancy Placenta Previa Previous PPH Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2)) Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder. Contraindication to carbetocin and oxytocin Language Barrier Women undergoing general anaesthesia Women who has abnormal baseline ECG that suggestive myocardial ischemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbetocin<br>Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal | Drug: Carbetocin<br>* IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group. pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.<br>* Other names: pitocin for oxytocin;|
| Active Comparator: Oxytocin<br>Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group. | Drug: Oxytocin<br>* 5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.<br>* Other names: pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic effects | Haemodynamic effect (blood pressure, heart rate, saturation of oxygen) Presence of ECG changes such as ST depression and changes in T-waves Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain) To compare the troponin T levels | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss measurement | Need for additional oxytocin infusion Total blood loss Drop in haemoglobin level post-operatively | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, anaesthesia, caesarean section