Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Universiti Kebangsaan Malaysia Medical Centre
Sponsor:
Information provided by (Responsible Party):
Nirmala Chandralega Kampan, Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier:
NCT01719952
First received: July 6, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Pregnancy Related
Anaesthesia
Drug: Carbetocin
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universiti Kebangsaan Malaysia Medical Centre:

Primary Outcome Measures:
  • Haemodynamic effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Blood loss measurement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    1. Need for additional oxytocin infusion
    2. Total blood loss
    3. Drop in haemoglobin level post-operatively


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: pitocin

Detailed Description:

OUTCOME MEASURES The drop of 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.

The drop of 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719952

Locations
Malaysia
Department of O&G Recruiting
Cheras, Kuala Lumpur, Malaysia, 56000
Contact: Nirmala C Kampan, MRCOG(UK)    60391455950 ext 5949    nirmala_k@hotmail.com   
Principal Investigator: Nirmala C Kampan, MRCOG(UK)         
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
Principal Investigator: Nirmala C Kampan, MRCOG(UK) Universiti Kebangsaan Malaysia Medical Centre
  More Information

No publications provided

Responsible Party: Nirmala Chandralega Kampan, MRCOG(UK), Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT01719952     History of Changes
Other Study ID Numbers: UKMMC
Study First Received: July 6, 2012
Last Updated: September 30, 2014
Health Authority: Malaysia: Institutional Review Board

Keywords provided by Universiti Kebangsaan Malaysia Medical Centre:
pregnancy
anaesthesia
caesarean section

Additional relevant MeSH terms:
Carbetocin
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014