Postpartum HemorrhageNCT04182360
Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.
A study testing Carbetocin in people with Postpartum Hemorrhage and Twin, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. 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, Twin
- 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2021to 28 Apr 2023
- 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
- Twin Pregnancy
- Elective cesarean delivery under regional anesthesia
- Gestational age ≥ 36 weeks
- No known additional risk factors for postpartum hemorrhage
- Written informed consent to participate in this study
Who cannot join
- Refusal to give written informed consent
- Allergy or hypersensitivity to oxytocin
- Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40
- Hepatic, renal, and vascular disease
- Use of general anesthesia prior to the administration of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in achieving adequate uterine tone at elective cesarean section.
In these dose-finding studies, women with multiple pregnancies have been excluded. Because women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy, prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is required. This question remains unanswered.
The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100 mcg.
Read the detailed description
There is a lack of consensus as to what the optimal uterotonic regime is globally. Furthermore, variability in the international guidelines regarding the choice of first line uterotonic in prevention of PPH adds to the confusion. With the widespread availability of carbetocin in some developed countries, including Canada, the question of which uterotonic to adopt and at which dose becomes even more difficult to ascertain. Studies that have currently been published suggest the ED90 doses of carbetocin and oxytocin provide adequate uterine contraction with possibly fewer side effects associated with the lower dose regimens. There is evidence to suggest that lower doses of both carbetocin provide equivalent uterine contractions with a better side effect profile in patients with a singleton pregnancy. However, there is no clinical dosing data specifically for patients with twin pregnancy. The results of our study will provide guidance to obstetric and anesthetic providers worldwide when deciding what dose of carbetocin to use in women with twin pregnancy.
- Conditions
- Postpartum Hemorrhage, Twin
- Being tested
- Carbetocin
- Keywords
- Pregnancy, Twins, Postpartum hemorrhage, carbetocin, uterotonic, cesarean delivery
- 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 administered intravenously, over 1 minute following delivery of the fetal head.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin 10mcg | Active comparator | Patient is given 10mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. Receives: Drug: Carbetocin |
| Carbetocin 20mcg | Active comparator | Patient is given 20mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. Receives: Drug: Carbetocin |
| Carbetocin 40mcg | Active comparator | Patient is given 40mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. Receives: Drug: Carbetocin |
| Carbetocin 60mcg | Active comparator | Patient is given 60mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. Receives: Drug: Carbetocin |
| Carbetocin 80mcg | Active comparator | Patient is given 80mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. Receives: Drug: Carbetocin |
| Carbetocin 100mcg | Active comparator | Patient is given 100mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tone 2 minutes: questionnaire
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the carbetocin injection.
Measured: 2 minutes
Secondary outcomes (16)
Uterine tone 5 minutes: questionnaire
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 5 minutes after completion of the carbetocin injection.
Measured: 5 minutes
Additional uterotonics administered
The drug, dosage and timing of any additional uterotonic medication given during surgery.
Measured: 1 hour
Estimated blood loss
Blood loss will be calculated through the difference in hematocrit values assessed prior to surgery and 24 hours after the cesarean delivery.
Measured: 24 hours
Intravenous fluid administered during surgery
The total volume (ml) of fluid administered from entering the operating room to skin closure.
Measured: 2 hours
Hypotension: systolic blood pressure less than 80% of baseline
Systolic blood pressure < 80% of baseline, from drug administration until end of surgery
Measured: 2 hours
Tachycardia: heart rate greater than 130% of baseline
Heart rate > 130% of baseline, from drug administration until end of surgery
Measured: 2 hours
Bradycardia: heart rate less than 70% of baseline
Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery
Measured: 2 hours
Presence of ventricular tachycardia: ECG
Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery
Measured: 2 hours
Presence of atrial fibrillation: ECG
Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery
Measured: 2 hours
Presence of atrial flutter: ECG
Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery
Measured: 2 hours
Presence of nausea: questionnaire
The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient
Measured: 2 hours
Presence of vomiting: questionnaire
The presence of vomiting and number of episodes, from drug administration until end of surgery
Measured: 2 hours
Presence of chest pain: questionnaire
Any presence of chest pain, from drug administration until end of surgery, as reported by the patient
Measured: 2 hours
Presence of shortness of breath: questionnaire
Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient
Measured: 2 hours
Presence of headache: questionnaire
Any presence of headache, from drug administration until end of surgery, as reported by the patient
Measured: 2 hours
Presence of flushing: questionnaire
Any presence of flushing, from drug administration until end of surgery
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 posted2 Dec 2019
- Study start14 Oct 2021
- Primary completion27 Apr 2023
- Study completion28 Apr 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Biased coin up-and-down design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182360
- Sponsor's protocol ID
- 19-07
- Status last verified
- Jul 2023
- First submitted
- 27 Nov 2019
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.
- ClinicalTrials.gov ID
- NCT04182360
- Acronym / sponsor ID
- 19-07
- Conditions
- Postpartum Hemorrhage, Twin
- Keywords
- Pregnancy, Twins, Postpartum hemorrhage, carbetocin, uterotonic, cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 2 Dec 2019 (actual)
- 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.
Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in achieving adequate uterine tone at elective cesarean section.
In these dose-finding studies, women with multiple pregnancies have been excluded. Because women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy, prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is required. This question remains unanswered.
The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100 mcg.
Detailed description
There is a lack of consensus as to what the optimal uterotonic regime is globally. Furthermore, variability in the international guidelines regarding the choice of first line uterotonic in prevention of PPH adds to the confusion. With the widespread availability of carbetocin in some developed countries, including Canada, the question of which uterotonic to adopt and at which dose becomes even more difficult to ascertain. Studies that have currently been published suggest the ED90 doses of carbetocin and oxytocin provide adequate uterine contraction with possibly fewer side effects associated with the lower dose regimens. There is evidence to suggest that lower doses of both carbetocin provide equivalent uterine contractions with a better side effect profile in patients with a singleton pregnancy. However, there is no clinical dosing data specifically for patients with twin pregnancy. The results of our study will provide guidance to obstetric and anesthetic providers worldwide when deciding what dose of carbetocin to use in women with twin pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Biased coin up-and-down design.
| Arm | Type | Receives |
|---|---|---|
| Carbetocin 10mcg | Active comparator | Drug: CarbetocinPatient is given 10mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. |
| Carbetocin 20mcg | Active comparator | Drug: CarbetocinPatient is given 20mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. |
| Carbetocin 40mcg | Active comparator | Drug: CarbetocinPatient is given 40mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. |
| Carbetocin 60mcg | Active comparator | Drug: CarbetocinPatient is given 60mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. |
| Carbetocin 80mcg | Active comparator | Drug: CarbetocinPatient is given 80mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. |
| Carbetocin 100mcg | Active comparator | Drug: CarbetocinPatient is given 100mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Twin Pregnancy
- Elective cesarean delivery under regional anesthesia
- Gestational age ≥ 36 weeks
- No known additional risk factors for postpartum hemorrhage
- Written informed consent to participate in this study
Key exclusion criteria (5 listed)
- Refusal to give written informed consent
- Allergy or hypersensitivity to oxytocin
- Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40
- Hepatic, renal, and vascular disease
- Use of general anesthesia prior to the administration of the study drug
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 administered intravenously, over 1 minute following delivery of the fetal head. | Drug | Carbetocin 100mcg, Carbetocin 10mcg, Carbetocin 20mcg, Carbetocin 40mcg, Carbetocin 60mcg, Carbetocin 80mcg |
Primary outcome
Uterine tone 2 minutes: questionnaire
Time frame: 2 minutes
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the carbetocin injection.
16 secondary outcomes
Uterine tone 5 minutes: questionnaire
Time frame: 5 minutes
Additional uterotonics administered
Time frame: 1 hour
Estimated blood loss
Time frame: 24 hours
Intravenous fluid administered during surgery
Time frame: 2 hours
Hypotension: systolic blood pressure less than 80% of baseline
Time frame: 2 hours
Tachycardia: heart rate greater than 130% of baseline
Time frame: 2 hours
Bradycardia: heart rate less than 70% of baseline
Time frame: 2 hours
Presence of ventricular tachycardia: ECG
Time frame: 2 hours
Presence of atrial fibrillation: ECG
Time frame: 2 hours
Presence of atrial flutter: ECG
Time frame: 2 hours
Presence of nausea: questionnaire
Time frame: 2 hours
Presence of vomiting: questionnaire
Time frame: 2 hours
Presence of chest pain: questionnaire
Time frame: 2 hours
Presence of shortness of breath: questionnaire
Time frame: 2 hours
Presence of headache: questionnaire
Time frame: 2 hours
Presence of flushing: questionnaire
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 6 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade 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.
Jose Carvalho, 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 and Twin, 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 5 inclusion and 5 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 Jul 2023. 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?
Uterine tone 2 minutes: questionnaire (time frame: 2 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 6 Jul 2023.