Postpartum HemorrhageNCT01725243
Carbetocin at Cesarean Delivery for Labor Arrest
A study testing Carbetocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Apr 2013
- Phase
- Interventional
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients who have given written informed consent to participate in this study.
- All patients planned for uncomplicated low transverse cesarean delivery secondary to labor arrest, under epidural anesthesia.
- ≥37 week pregnancy
- Singleton pregnancy
- Patients who have received oxytocin for at least 4 hours for labor augmentation
- ASA 1 or 2
Who cannot join
- Refusal or inability to obtain informed consent.
- All patients who claim allergy or hypersensitivity to oxytocin and carbetocin.
- Previous history of uterine atony or PPH
- Risk factors for PPH such as pre-eclampsia, polyhydramnios, uterine fibroids, bleeding diathesis and chorioamnionitis etc.
- Abnormal placental implantation (known or suspected)
- > 3 cesarean sections in the past
Show all 16Show fewer
- Previous classic uterine incision
- Macrosomia - Estimated fetal weight > 4500g
- Hemoglobin < 100g/L
- Cesarean section under general anesthesia
- ASA 3 and 4 or patients with hepatic, renal, cardiac (eg. Coronary artery disease) and vascular disease
- Genital development problems (eg. Abnormal uterus, cervix, vagina, etc.)
- Uncontrolled hypotension or hypertension
- Uncontrolled diabetes
- Abnormal heart rhythms and bradycardia
- Drug abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin at Cesarean Delivery for Labor Arrest: A Dose Finding Study
In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.
Read the detailed description
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate.
The evidence reported for Carbetocin use in the literature has mostly been based upon low risk non-laboring patients undergoing elective cesarean deliveries. At present, only 2 studies have looked at the use of Carbetocin in low risk patients requiring emergency cesarean deliveries. The minimum effective dose (ED90) of carbetocin in laboring women has not been determined so far. Similar to oxytocin, the ED90 of Carbetocin is likely to be higher in laboring women undergoing Cesarean deliveries as compared to the non-laboring women, due to the effect of the desensitization phenomenon.
This study will be conducted as a prospective, randomized, up-down sequential allocation trial. The success or fail of a patient in the study will determine the dose given to future patients. Dosage will be increased for patients following a failed case, and kept the same for patients following successful cases. Following a successful case, there is also a 1 in 9 chance that the dose will be decreased for the next patient.
The results of this study will establish the minimum effective dose of carbetocin for uterine contraction at cesarean delivery for labor arrest. This will likely minimize unnecessary side effects caused by a large bolus dose of the drug, and improve quality and safety of patient care.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin
- Keywords
- pregnancy, postpartum hemorrhage, Cesarean delivery, carbetocin, failure to progress in labor
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Duratocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin 10mcg | Active comparator | Carbetocin 10mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 20mcg | Active comparator | Carbetocin 20mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 40mcg | Active comparator | Carbetocin 40mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 60mcg | Active comparator | Carbetocin 60mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 80mcg | Active comparator | Carbetocin 80mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 100mcg | Active comparator | Carbetocin 100mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 120mcg | Active comparator | Carbetocin 120mcg IV, once following delivery. Receives: Drug: Carbetocin |
| Carbetocin 140mcg | Active comparator | Carbetocin 140mcg IV, once following delivery. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for additional uterotonics
need for additional uterotonics in the OR at the time of cesarean section based upon the assessment of unsatisfactory/indeterminate uterine tone in response to the single bolus of carbetocin.
Measured: 30 minutes
Secondary outcomes (5)
uterine tone
Incidence of satisfactory, unsatisfactory and indeterminate uterine tone at every minute for five minutes and at 10 minutes following the completion of the injection of carbetocin.
Measured: 10 minutes
uterine tone
Incidence of satisfactory, unsatisfactory/ indeterminate uterine tone as determined by the obstetrician/nurse after trans-abdominal palpation of the uterus in PACU within 2 hours of delivery of the placenta
Measured: 2 hours
need for additional uterotonic
Need for delayed additional uterotonics within 24 hours after delivery outside the OR.
Measured: 24 hours
Blood loss
Estimated blood loss will be calculated using blood results prior to the cesarean delivery and 24 hours post-delivery.
Measured: 24 hours
side effects
Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725243
- Sponsor's protocol ID
- 12-07
- Status last verified
- May 2013
- First submitted
- 8 Nov 2012
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nguyen-Lu N, Carvalho JC, Farine D, Seaward G, Ye XY, Balki M. Carbetocin at Cesarean delivery for labour arrest: a sequential allocation trial to determine the effective dose. Can J Anaesth. 2015 Aug;62(8):866-74. doi: 10.1007/s12630-015-0375-2. Epub 2015 Apr 10.
PubMed 25860126
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin at Cesarean Delivery for Labor Arrest: A Dose Finding Study
- ClinicalTrials.gov ID
- NCT01725243
- Acronym / sponsor ID
- 12-07
- Conditions
- Postpartum Hemorrhage
- Keywords
- pregnancy, postpartum hemorrhage, Cesarean delivery, carbetocin, failure to progress in labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Nov 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.
In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.
Detailed description
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate.
The evidence reported for Carbetocin use in the literature has mostly been based upon low risk non-laboring patients undergoing elective cesarean deliveries. At present, only 2 studies have looked at the use of Carbetocin in low risk patients requiring emergency cesarean deliveries. The minimum effective dose (ED90) of carbetocin in laboring women has not been determined so far. Similar to oxytocin, the ED90 of Carbetocin is likely to be higher in laboring women undergoing Cesarean deliveries as compared to the non-laboring women, due to the effect of the desensitization phenomenon.
This study will be conducted as a prospective, randomized, up-down sequential allocation trial. The success or fail of a patient in the study will determine the dose given to future patients. Dosage will be increased for patients following a failed case, and kept the same for patients following successful cases. Following a successful case, there is also a 1 in 9 chance that the dose will be decreased for the next patient.
The results of this study will establish the minimum effective dose of carbetocin for uterine contraction at cesarean delivery for labor arrest. This will likely minimize unnecessary side effects caused by a large bolus dose of the drug, and improve quality and safety of patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Carbetocin 10mcg | Active comparator | Drug: CarbetocinCarbetocin 10mcg IV, once following delivery. |
| Carbetocin 20mcg | Active comparator | Drug: CarbetocinCarbetocin 20mcg IV, once following delivery. |
| Carbetocin 40mcg | Active comparator | Drug: CarbetocinCarbetocin 40mcg IV, once following delivery. |
| Carbetocin 60mcg | Active comparator | Drug: CarbetocinCarbetocin 60mcg IV, once following delivery. |
| Carbetocin 80mcg | Active comparator | Drug: CarbetocinCarbetocin 80mcg IV, once following delivery. |
| Carbetocin 100mcg | Active comparator | Drug: CarbetocinCarbetocin 100mcg IV, once following delivery. |
| Carbetocin 120mcg | Active comparator | Drug: CarbetocinCarbetocin 120mcg IV, once following delivery. |
| Carbetocin 140mcg | Active comparator | Drug: CarbetocinCarbetocin 140mcg IV, once following delivery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All patients who have given written informed consent to participate in this study.
- All patients planned for uncomplicated low transverse cesarean delivery secondary to labor arrest, under epidural anesthesia.
- ≥37 week pregnancy
- Singleton pregnancy
- Patients who have received oxytocin for at least 4 hours for labor augmentation
Key exclusion criteria (16 listed)
- Refusal or inability to obtain informed consent.
- All patients who claim allergy or hypersensitivity to oxytocin and carbetocin.
- Previous history of uterine atony or PPH
- Risk factors for PPH such as pre-eclampsia, polyhydramnios, uterine fibroids, bleeding diathesis and chorioamnionitis etc.
- Abnormal placental implantation (known or suspected)
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: DuratocinCarbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg | Drug | Carbetocin 100mcg, Carbetocin 10mcg, Carbetocin 120mcg, Carbetocin 140mcg, Carbetocin 20mcg, Carbetocin 40mcg, Carbetocin 60mcg, Carbetocin 80mcg |
Primary outcome
need for additional uterotonics
Time frame: 30 minutes
need for additional uterotonics in the OR at the time of cesarean section based upon the assessment of unsatisfactory/indeterminate uterine tone in response to the single bolus of carbetocin.
5 secondary outcomes
uterine tone
Time frame: 10 minutes
uterine tone
Time frame: 2 hours
need for additional uterotonic
Time frame: 24 hours
Blood loss
Time frame: 24 hours
side effects
Time frame: 2 hours
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 30 May 2013.
- Derived from this study: PubMed 25860126Nguyen-Lu N, Carvalho JC, Farine D, Seaward G, Ye XY, Balki M. Carbetocin at Cesarean delivery for labour arrest: a sequential allocation trial to determine the effective dose. Can J Anaesth. 2015 Aug;62(8):866-74. doi: 10.1007/s12630-015-0375-2. Epub 2015 Apr 10.
Related trials for Postpartum Hemorrhage
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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.
Mrinalini Balki, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai 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 6 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: finished, as of the sponsor's last update on 30 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.
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?
need for additional uterotonics (time frame: 30 minutes). 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 NCT01725243, which also lists 1 linked publication.
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 30 May 2013.