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NCT Number: NCT01719952

Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

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.

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Key information

Conditions

Pregnancy Related Anaesthesia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of O&G

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbetocin

Drug

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

Oxytocin

Drug

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

Primary outcomes

  1. Haemodynamic effects

    Time frame: 2 years

    • 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

Secondary outcomes

  1. Blood loss measurement

    Time frame: 2 years

    • Need for additional oxytocin infusion
    • Total blood loss
    • Drop in haemoglobin level post-operatively

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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