Uterine AtonyPhase 4NCT01630187
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
A Phase 4 study testing Carbetocin in people with Uterine Atony and Post-partum Hemorrhage, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Atony, Post-partum Hemorrhage
- What is being tested?
- Carbetocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Jul 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- ≥ 37-week pregnancy
- singleton pregnancy
- elective cesarean section with a low transverse incision
- ASA I or II
Who cannot join
- Personal history of uterine atony or postpartum hemorrhage
- Abnormal placental implantation (known or suspected)
- > 3 cesarean sections in the past
- Personal history of a classic uterine incision
- Estimated fetal weight > 4500g
- Hemoglobin < 100 g/L
Show all 11Show fewer
- Regular use of tocolytic drugs
- Cesarean section under general anesthesia
- Known allergy to carbetocin
- Refusal
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.
Read the detailed description
Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.
Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.
- Conditions
- Uterine Atony, Post-partum Hemorrhage
- Being tested
- Carbetocin
- Keywords
- Carbetocin, Uterotonic drug, elective cesarean section
- Medical subject headings
- Uterine Inertia, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Administration of carbetocin 50 mcg , after clamping the umbilical cord
CarbetocinDrug
Administration of carbetocin 100 mcg , after clamping the umbilical cord
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin 100 mcg | Active comparator | Not described Receives: Drug: Carbetocin |
| Carbetocin 50 mcg | Experimental | Not described Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of a second uterotonic drug
Measured: First 48 hours of the postpartum
Secondary outcomes (3)
Incidence of side effects
Measured: During the fifteen minutes following the administration of carbetocin
Incidence of major complications
Measured: First 48 hours of the postpartum
Drop in hemoglobin measurement
Measured: on the second post-partum day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine AtonyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Bédard, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630187
- Sponsor's protocol ID
- CARB-011
- Status last verified
- May 2013
- First submitted
- 17 May 2012
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01630187
- Acronym / sponsor ID
- CARB-011
- Conditions
- Uterine Atony, Post-partum Hemorrhage
- Keywords
- Carbetocin, Uterotonic drug, elective cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jun 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 study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.
Detailed description
Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.
Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.
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 100 mcg | Active comparator | Drug: Carbetocin |
| Carbetocin 50 mcg | Experimental | Drug: Carbetocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old
- ≥ 37-week pregnancy
- singleton pregnancy
- elective cesarean section with a low transverse incision
- ASA I or II
Key exclusion criteria (11 listed)
- Personal history of uterine atony or postpartum hemorrhage
- Abnormal placental implantation (known or suspected)
- > 3 cesarean sections in the past
- Personal history of a classic uterine incision
- Estimated fetal weight > 4500g
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 |
|---|---|---|
| CarbetocinAdministration of carbetocin 50 mcg , after clamping the umbilical cord | Drug | Carbetocin 50 mcg |
| CarbetocinAdministration of carbetocin 100 mcg , after clamping the umbilical cord | Drug | Carbetocin 100 mcg |
Primary outcome
Utilization of a second uterotonic drug
Time frame: First 48 hours of the postpartum
3 secondary outcomes
Incidence of side effects
Time frame: During the fifteen minutes following the administration of carbetocin
Incidence of major complications
Time frame: First 48 hours of the postpartum
Drop in hemoglobin measurement
Time frame: on the second post-partum day
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 29 May 2013.
Related trials for Uterine Atony
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingPhase 4
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 2
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Blood Loss, Surgical, Blood Loss, Postoperative
Recruiting
Administration Of Calcium Gluconate for The Reduction of Blood Loss During Vaginal Delivery
Postpartum 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.
Julie Bédard principal investigator
Laval University
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 Uterine Atony and Post-partum Hemorrhage, run by Laval University 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 5 inclusion and 11 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 29 May 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?
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?
Utilization of a second uterotonic drug (time frame: First 48 hours of the postpartum). 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 29 May 2013.