Postpartum HemorrhagePhase 4NCT01579201
ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
A Phase 4 study testing Carbetocin in people with Postpartum Hemorrhage and Uterine Atony, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony
- What is being tested?
- Carbetocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Mar 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy pregnant women (ASA I or II)
- Elective cesarean delivery
- Spinal anesthesia
- Term gestation (37 weeks and above)
Who cannot join
- Multiple gestation
- Known coagulopathy
- Active labour
- Uterine fibroids
- Body mass index > 45
- Emergency cesarean section
Show all 16Show fewer
- General anesthesia
- Any contraindication to neuraxial anesthesia
- Cardiopathies
- Known allergies to carbetocin
- Patient refusal
- Placenta previa/Placenta accreta
- Hypertensive disease/Preeclampsia/Eclampsia
- Polyhydramnios
- Previous history of uterine atony or postpartum hemorrhage
- Renal or liver disease
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Christian Loubert, MD, FRCPC, 514.252.3426, loubertch@yahoo.fr
Louis-Philippe Fortier, MD, FRCPC, 514.252.3426, lpfortier@mac.com
About this study
Official title: ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.
Read the detailed description
Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.
In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Being tested
- Carbetocin
- Keywords
- Postpartum Hemorrhage, Uterine Atony, Obstetric Anesthesia, Cesarean Section, Carbetocin
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Duratocin
First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Experimental | Not described Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of carbetocin which will prevent uterine atony in 90% of subjects
The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory.
Measured: 5 minutes
Secondary outcomes (5)
Incidence of side effects
Any of these side effects will be noted in the first 20 minutes following injection of carbetocin: hypotension, tachycardia, nausea, vomiting, flushing, headache, feeling of warmth, tremor, metallic taste, abdominal pain, back pain, chest pain and others.
Measured: 20 minutes
Vasopressors administered
The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.
Measured: 20 minutes
Anti nausea therapy
Measured: 20 minutes
Additional uterotonic medication administered
Measured: 20 minutes
Additional uterine massage
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Christian Loubert, Maisonneuve-Rosemont Hospital
- Investigators
- Christian Loubert, MD, FRCPC, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579201
- Sponsor's protocol ID
- LoubertHMR2012/01
- Status last verified
- Feb 2013
- First submitted
- 13 Apr 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01579201
- Acronym / sponsor ID
- LoubertHMR2012/01
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Keywords
- Postpartum Hemorrhage, Uterine Atony, Obstetric Anesthesia, Cesarean Section, Carbetocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 17 Apr 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.
The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.
Detailed description
Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.
In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Experimental | Drug: Carbetocin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy pregnant women (ASA I or II)
- Elective cesarean delivery
- Spinal anesthesia
- Term gestation (37 weeks and above)
Key exclusion criteria (16 listed)
- Multiple gestation
- Known coagulopathy
- Active labour
- Uterine fibroids
- Body mass index > 45
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: DuratocinFirst patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change. | Drug | Carbetocin |
Primary outcome
Dose of carbetocin which will prevent uterine atony in 90% of subjects
Time frame: 5 minutes
The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory.
5 secondary outcomes
Incidence of side effects
Time frame: 20 minutes
Vasopressors administered
Time frame: 20 minutes
Anti nausea therapy
Time frame: 20 minutes
Additional uterotonic medication administered
Time frame: 20 minutes
Additional uterine massage
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Christian Loubert, MD, FRCPC principal investigator
Maisonneuve-Rosemont Hospital
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 Postpartum Hemorrhage and Uterine Atony, run by Maisonneuve-Rosemont Hospital 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Loubert, MD, FRCPC (514.252.3426, loubertch@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of carbetocin which will prevent uterine atony in 90% of subjects (time frame: 5 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 15 Feb 2013.