Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

N/ACompletedNCT01719952

Universiti Kebangsaan Malaysia Medical Centre50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pregnancy Related Anaesthesia

Interventions

CarbetocinDRUG

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.

OxytocinDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS. 2. 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. 3. Ability to provide informed consent. Exclusion Criteria: 1. Emergency caesarean section 2. Preterm Labour 3. Grandmultipara 4. Multiple Pregnancy 5. Placenta Previa 6. Previous PPH 7. Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2)) 8. 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. 9. Contraindication to carbetocin and oxytocin 10. Language Barrier 11. Women undergoing general anaesthesia 12. Women who has abnormal baseline ECG that suggestive myocardial ischemia

Outcomes

Primary Outcomes

Haemodynamic effects

1. Haemodynamic effect (blood pressure, heart rate, saturation of oxygen) 2. Presence of ECG changes such as ST depression and changes in T-waves 3. Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain) 4. To compare the troponin T levels

Time frame: 2 years

Secondary Outcomes

Blood loss measurement

1. Need for additional oxytocin infusion 2. Total blood loss 3. Drop in haemoglobin level post-operatively