Effect of Carbetocin on Cardiovascular SystemPhase 4NCT02636816
Cardiovascular Effects of Carbetocin Given During Elective Cesarean
A Phase 4 study testing carbetocin in people with Effect of Carbetocin on Cardiovascular System and Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Carbetocin on Cardiovascular System, Pregnancy
- What is being tested?
- carbetocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Jun 2016
- Phase
- Phase 4
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective cesarean delivery under spinal,
- low risk for post partum hemorrhage,
- able to understand english
Who cannot join
- cesarean under general anesthesia,
- bleeding condition,
- placenta previa,
- unable to understand english
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™
The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.
Read the detailed description
Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.
- Being tested
- carbetocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbetocinDrug
Also called Duratocin
drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| Infusion | Experimental | carbetocin is given slowly Receives: Drug: carbetocin |
| Bolus | Active comparator | carbetocin is given quickly Receives: Drug: carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change in cardiac output parameters as measured by non-invasive cardiac output monitor
the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period
Measured: 10 minutes
Secondary outcomes (1)
incidence of side effects occurring within timeframe below
headache, nausea, vomiting, facial flushing
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Carbetocin on Cardiovascular SystemStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Vit Gunka, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636816
- Sponsor's protocol ID
- H15-03007
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™
- ClinicalTrials.gov ID
- NCT02636816
- Acronym / sponsor ID
- H15-03007
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Dec 2015 (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.
The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.
Detailed description
Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infusion | Experimental | Drug: carbetocincarbetocin is given slowly |
| Bolus | Active comparator | Drug: carbetocincarbetocin is given quickly |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective cesarean delivery under spinal,
- low risk for post partum hemorrhage,
- able to understand english
Key exclusion criteria (4 listed)
- cesarean under general anesthesia,
- bleeding condition,
- placenta previa,
- unable to understand english
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: Duratocindrug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery. | Drug | Bolus, Infusion |
Primary outcome
percent change in cardiac output parameters as measured by non-invasive cardiac output monitor
Time frame: 10 minutes
the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period
1 secondary outcome
incidence of side effects occurring within timeframe below
Time frame: 30 minutes
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 17 Nov 2016.
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.
Vit Gunka, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbetocin in people with Effect of Carbetocin on Cardiovascular System and Pregnancy, run by University of British Columbia at 1 site in Canada.
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 4 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 17 Nov 2016. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percent change in cardiac output parameters as measured by non-invasive cardiac output monitor (time frame: 10 minutes). 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 17 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.