Pregnancy RelatedNCT01719952
Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin
A study testing Carbetocin and Oxytocin in people with Pregnancy Related and Anaesthesia, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related, Anaesthesia
- What is being tested?
- Carbetocin and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Emergency caesarean section
- Preterm Labour
- Grandmultipara
- Multiple Pregnancy
- Placenta Previa
- Previous PPH
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related, Anaesthesia
- Being tested
- Carbetocin, Oxytocin
- Keywords
- pregnancy, anaesthesia, caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Duratocin for carbetocin, pitocin for oxytocin
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.
OxytocinDrug
Also called pitocin
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.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Experimental | Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal Receives: Drug: Carbetocin |
| Oxytocin | Active comparator | 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. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Blood loss measurement
- Need for additional oxytocin infusion
- Total blood loss
- Drop in haemoglobin level post-operatively
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirmala Chandralega Kampan, Universiti Kebangsaan Malaysia Medical Centre
- Investigators
- Nirmala C Kampan, MRCOG(UK), Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719952
- Sponsor's protocol ID
- UKMMC
- Status last verified
- Feb 2015
- First submitted
- 6 Jul 2012
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01719952
- Acronym / sponsor ID
- UKMMC
- Conditions
- Pregnancy Related, Anaesthesia
- Keywords
- pregnancy, anaesthesia, caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Experimental | Drug: CarbetocinCarbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal |
| Oxytocin | Active comparator | Drug: OxytocinOther 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Emergency caesarean section
- Preterm Labour
- Grandmultipara
- Multiple Pregnancy
- Placenta Previa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbetocinAlso: Duratocin for carbetocin, pitocin for oxytocinIV 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. | Drug | Carbetocin |
| OxytocinAlso: pitocin5 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. | Drug | Oxytocin |
Primary outcome
Haemodynamic effects
Time frame: 2 years
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
1 secondary outcome
Blood loss measurement
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nirmala C Kampan, MRCOG(UK) principal investigator
Universiti Kebangsaan Malaysia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin and Oxytocin in people with Pregnancy Related and Anaesthesia, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic effects (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.