Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

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

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.

Study Overview

• Status: Completed
• Conditions: Anaesthesia; Pregnancy Related
• Intervention / Treatment: Drug: Carbetocin; Drug: Oxytocin

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Department of O&G

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbetocin; Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal	Drug: Carbetocin; 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.; Other Names: Duratocin for carbetocin; pitocin for oxytocin
Active Comparator: Oxytocin; 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; 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.; Other Names: pitocin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Nirmala C Kampan, MRCOG(UK), Universiti Kebangsaan Malaysia Medical Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 27, 2015
• Last Update Submitted That Met QC Criteria: February 26, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: pregnancy; anaesthesia; caesarean section
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: UKMMC