Complications; Cesarean SectionPhase 4CARBETOCINNCT02221531
Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN
A Phase 4 study testing Carbetocin Short-infusion and Carbetocin Bolus application in people with Complications; Cesarean Section and Anesthesia; Reaction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Complications; Cesarean Section, Anesthesia; Reaction
- What is being tested?
- Carbetocin Short-infusion and Carbetocin Bolus application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to Nov 2015
- 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 18 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- healthy women
- singleton pregnancy
- caesarean section under regional anaesthesia
- older than 18 years
- written informed consent
Who cannot join
- emergency caesarean section
- secondary caesarean section due to fetal distress
- comorbidities (cardiovascular, kidney or liver disorder, epilepsy)
- obstetric diseases (hypertension, (pre-)eclampsia)
- uterine malformation (including uterine fibroids)
- bleeding disorder
- known hypersensitivity to carbetocin or oxytocin
- fetal malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion
Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.
A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).
- Being tested
- Carbetocin Short-infusion, Carbetocin Bolus application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbetocin Short-infusionDrug
Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)
Carbetocin Bolus applicationDrug
Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| Short infusion | Experimental | Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute Receives: Drug: Carbetocin Short-infusion |
| Bolus application | Other | Carbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds Receives: Drug: Carbetocin Bolus application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal uterine tone
Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100
Measured: within the first 5 minutes after cord clamping
Secondary outcomes (1)
Mean arterial pressure
mean arterial pressure is measured by a non-invasive blood pressure cuff at the upper arm
Measured: within first five minutes after cord clamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetric Anaesthetists' Association United Kingdom
- Responsible party
- Sponsor
- Investigators
- Salome Dell-Kuster, MD, Principal investigator, Department of Anaesthesiology, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221531
- Sponsor's protocol ID
- 2014-088
- Acronym
- CARBETOCIN
- Status last verified
- Jan 2018
- First submitted
- 19 Aug 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dell-Kuster S, Hoesli I, Lapaire O, Seeberger E, Steiner LA, Bucher HC, Girard T. Efficacy and safety of carbetocin given as an intravenous bolus compared with short infusion for Caesarean section - double-blind, double-dummy, randomized controlled non-inferiority trial. Br J Anaesth. 2017 May 1;118(5):772-780. doi: 10.1093/bja/aex034.
PubMed 28498927Dell-Kuster S, Hoesli I, Lapaire O, Seeberger E, Steiner LA, Bucher HC, Girard T. Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial. Trials. 2016 Mar 22;17:155. doi: 10.1186/s13063-016-1285-5.
PubMed 27004531
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion
- ClinicalTrials.gov ID
- NCT02221531
- Acronym / sponsor ID
- CARBETOCIN / 2014-088
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Obstetric Anaesthetists' Association United Kingdom
- Study start
- Aug 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Aug 2014 (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.
Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.
A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).
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 |
|---|---|---|
| Short infusion | Experimental | Drug: Carbetocin Short-infusionCarbetocin 100 microgram will be applied intravenously in a short infusion over about a minute |
| Bolus application | Other | Drug: Carbetocin Bolus applicationCarbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy women
- singleton pregnancy
- caesarean section under regional anaesthesia
- older than 18 years
- written informed consent
Key exclusion criteria (8 listed)
- emergency caesarean section
- secondary caesarean section due to fetal distress
- comorbidities (cardiovascular, kidney or liver disorder, epilepsy)
- obstetric diseases (hypertension, (pre-)eclampsia)
- uterine malformation (including uterine fibroids)
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 |
|---|---|---|
| Carbetocin Short-infusionShort-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method) | Drug | Short infusion |
| Carbetocin Bolus applicationCarbetocin 100 microgram given intravenously as a bolus application over about 15 seconds | Drug | Bolus application |
Primary outcome
Maximal uterine tone
Time frame: within the first 5 minutes after cord clamping
Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100
1 secondary outcome
Mean arterial pressure
Time frame: within first five minutes after cord clamping
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 9 Jan 2018.
- Derived from this study: PubMed 28498927Dell-Kuster S, Hoesli I, Lapaire O, Seeberger E, Steiner LA, Bucher HC, Girard T. Efficacy and safety of carbetocin given as an intravenous bolus compared with short infusion for Caesarean section - double-blind, double-dummy, randomized controlled non-inferiority trial. Br J Anaesth. 2017 May 1;118(5):772-780. doi: 10.1093/bja/aex034.
- Derived from this study: PubMed 27004531Dell-Kuster S, Hoesli I, Lapaire O, Seeberger E, Steiner LA, Bucher HC, Girard T. Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial. Trials. 2016 Mar 22;17:155. doi: 10.1186/s13063-016-1285-5.
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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.
Salome Dell-Kuster, MD principal investigator
Department of Anaesthesiology, University Hospital Basel, Switzerland
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 Short-infusion and Carbetocin Bolus application in people with Complications; Cesarean Section and Anesthesia; Reaction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 8 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 9 Jan 2018. 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 Switzerland. 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?
Maximal uterine tone (time frame: within the first 5 minutes after cord clamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221531, which also lists 2 linked publications.
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 9 Jan 2018.