Effects of; Anesthesia, in PregnancyPhase 4NCT00977769
Carbetocin Versus Oxytocin and Hemodynamic Effects
A Phase 4 study testing carbetocin 100 µg and oxytocin 5 u in people with Effects of; Anesthesia, in Pregnancy, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Effects of; Anesthesia, in Pregnancy
- What is being tested?
- carbetocin 100 µg and oxytocin 5 u
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy pregnant women for planned cesarean section
Who cannot join
- Bleeding disorders
- Placenta disorders
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet
Oslo, 0027
Division of Anesthesia and Intensive Care Medicine
Oslo, 0027
About this study
Official title: Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
Read the detailed description
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
- Conditions
- Effects of; Anesthesia, in Pregnancy
- Being tested
- carbetocin 100 µg, oxytocin 5 u, placebo (NaCl)
- Keywords
- cesarean delivery, blood pressure, cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbetocin 100 µgDrug
Also called Pabal, injection
Hemodynamic effect of
oxytocin 5 uDrug
Also called Syntocinon, injection
Hemodynamic effect of
placebo (NaCl)Drug
Also called Saline, injection
Hemodynamic effect of
| Study group | Role | What they receive |
|---|---|---|
| carbetocin 100 µg | Experimental | Carbetocin injection, 100µg, single injection Receives: Drug: carbetocin 100 µg |
| oxytocin 5 u | Active comparator | Oxytocin 5U, injection, single injection Receives: Drug: oxytocin 5 u |
| placebo (NaCl) | Placebo comparator | Saline single injection Receives: Drug: placebo (NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
Measured: 2.5 minutes
Arterial Blood Pressure
The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
Measured: 2.5 min
Secondary outcomes (1)
Bleeding
The calculated estimated blood loss from delivery until 2 h after intervention
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effects of; Anesthesia, in PregnancyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
- Investigators
- Leiv Arne Rosseland, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977769
- Sponsor's protocol ID
- 2009carb
- Status last verified
- Apr 2014
- First submitted
- 15 Sep 2009
- Last updated
- 6 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesaeter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.
PubMed 23598289Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.
PubMed 34127491
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.
- ClinicalTrials.gov ID
- NCT00977769
- Acronym / sponsor ID
- 2009carb
- Conditions
- Effects of; Anesthesia, in Pregnancy
- Keywords
- cesarean delivery, blood pressure, cardiac output
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Posted 6 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
Detailed description
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| carbetocin 100 µg | Experimental | Drug: carbetocin 100 µgCarbetocin injection, 100µg, single injection |
| oxytocin 5 u | Active comparator | Drug: oxytocin 5 uOxytocin 5U, injection, single injection |
| placebo (NaCl) | Placebo comparator | Drug: placebo (NaCl)Saline single injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy pregnant women for planned cesarean section
Key exclusion criteria (2 listed)
- Bleeding disorders
- Placenta disorders
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 100 µgAlso: Pabal, injectionHemodynamic effect of | Drug | carbetocin 100 µg |
| oxytocin 5 uAlso: Syntocinon, injectionHemodynamic effect of | Drug | oxytocin 5 u |
| placebo (NaCl)Also: Saline, injectionHemodynamic effect of | Drug | placebo (NaCl) |
Primary outcome
Cardiac Output
Time frame: 2.5 minutes
The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
Arterial Blood Pressure
Time frame: 2.5 min
The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
1 secondary outcome
Bleeding
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23598289Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesaeter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.
- Derived from this study: PubMed 34127491Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.
Related trials for Effects of; Anesthesia, in Pregnancy
Not yet recruitingObservational study
Effect of Anesthesia Type on Surgeon Workload During Endoscopic Kidney Stone Surgery
Kidney Calculi
Recruiting
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
Kidney Disease, End-Stage, Kidney Transplant
Recruiting
Spinal Versus General Anesthesia in Open Simple Prostatectomy
Urologic Neoplasms, Benign Prostatic Hyperplasia
Recruiting
The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration
First Trimester Abortion, Surgical Abortion
Not yet recruiting
Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia
Pregnancy, Cesarean Section
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.
Leiv Arne Rosseland, MD PhD principal investigator
Oslo University Hospital
2 sites 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 100 µg and oxytocin 5 u in people with Effects of; Anesthesia, in Pregnancy, run by Oslo University Hospital at 2 sites in Norway.
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 1 inclusion and 2 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiac Output (time frame: 2.5 minutes). The study lists 2 primary outcomes in all. 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 NCT00977769, 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 6 May 2014.