DRUG
Carbetocin
Carbetocin administered intravenously, over 1 minute following delivery of the fetal head.
Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.
Status
Completed
Phase
Not applicable
Enrollment
30
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 2, 2019
Study start
Oct 14, 2021
Primary completion
Apr 27, 2023
Study completion
Apr 28, 2023
Results posted
Not reported
Registry updated
Jul 6, 2023
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
Uterine tone 5 minutes: questionnaire
Time frame · 5 minutes
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 5 minutes after completion of the carbetocin injection.
Additional uterotonics administered
Time frame · 1 hour
The drug, dosage and timing of any additional uterotonic medication given during surgery.
Estimated blood loss
Time frame · 24 hours
Blood loss will be calculated through the difference in hematocrit values assessed prior to surgery and 24 hours after the cesarean delivery.
Intravenous fluid administered during surgery
Time frame · 2 hours
The total volume (ml) of fluid administered from entering the operating room to skin closure.
Hypotension: systolic blood pressure less than 80% of baseline
Time frame · 2 hours
Systolic blood pressure \< 80% of baseline, from drug administration until end of surgery
Tachycardia: heart rate greater than 130% of baseline
Time frame · 2 hours
Heart rate \> 130% of baseline, from drug administration until end of surgery
Bradycardia: heart rate less than 70% of baseline
Time frame · 2 hours
Heart rate \< 70% of baseline or a heart rate \< 50bpm, from drug administration until end of surgery
Presence of ventricular tachycardia: ECG
Time frame · 2 hours
Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery
Presence of atrial fibrillation: ECG
Time frame · 2 hours
Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery
Presence of atrial flutter: ECG
Time frame · 2 hours
Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Mount Sinai Hospital
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Alex Ekwueme Federal University Teaching Hospital · Blood Loss, Surgical
Early Phase 1
Not yet recruiting
900
2026-07
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Mansoura University · Postpartum Hemorrhage · Uterine Atony
Phase 4
Not yet recruiting
332
2026-06
Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Sheba Medical Center · Postpartum Hemorrhage · Twin Pregnancy
Phase 4
Recruiting
120
2026-05
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage
Not applicable
Recruiting
32
2026-04
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Post Partum Hemorrhage
Not applicable
Recruiting
160
2026-04
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage (Primary)
Not applicable
Recruiting
120
2026-04
Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
Ankara Etlik City Hospital · Postpartum Hemorrhage \(PPH\)
Not applicable
Completed
300
2026-02
Carbetocin Myocardium Trial 2014 Part 2
Oslo University Hospital · Pregnancy Complications
Phase 4
Completed
240
2026-02
Related PeptideStat pages
Put the record in context.
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