Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin
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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 |
- Haemodynamic effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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
- Blood loss measurement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Need for additional oxytocin infusion
- Total blood loss
- Drop in haemoglobin level post-operatively
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated 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 by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group. compared to ocytocin regarding cardiovascular and haemodynamic effects 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:
|
|
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 |
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
Contacts and 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) | |
| 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: | October 30, 2012 |
| Health Authority: | Malaysia: Institutional Review Board |
Keywords provided by Universiti Kebangsaan Malaysia Medical Centre:
|
pregnancy anaesthesia caesarean section |
Additional relevant MeSH terms:
|
Oxytocin Carbetocin Oxytocics Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013