Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719952
• Other study ID #: UKMMC
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: February 26, 2015
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia
• Pregnancy Related

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malaysia	Department of O&G	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood loss measurement	Need for additional oxytocin infusion; Total blood loss; Drop in haemoglobin level post-operatively	2 years	No