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NCT02264769
Carbetocin at Elective Cesarean Deliveries: A Non-inferiority Study Between 20 and 100 Micrograms - Part 4
NA trial testing Carbetocin in Postpartum Hemorrhage in 110 participants. Completed in 1 May 2015.
1 April 2015
Quick facts
| Lead sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 1 October 2014 |
| Primary completion | 1 April 2015 |
| Estimated completion | 1 May 2015 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Carbetocin (CARBETOCIN) — full drug profile →
Conditions studied
- Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Who can join
Adults 18 to 50, female only, with Postpartum Hemorrhage. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Uterine tone
Time frame: 2 minutes
Uterine tone on a scale of 0-10 at 2 minutes after completion of injection of carbetocin.
Sponsor's own description
PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. 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 three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02264769
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Carbetocin
Trials testing the same drug.
- NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
- NCT06946589 — Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section · Phase 4 · not yet recruiting
- NCT06776926 — Timing of Carbetocin Administration in Postpartum Hemorrhage · NA · completed
- NCT06692621 — Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain · completed
- NCT07380529 — Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesar · NA · completed
Other recruiting trials for Postpartum Hemorrhage
Currently open trials in the same condition.
- NCT07401160 — Umbilical Cord Drainage to Prevent Postpartum Hemorrhage · NA · recruiting
- NCT07278037 — Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage · recruiting
- NCT07279545 — The Effect of Placental Cord Drainage on the Third Stage of Labor and the Amount of Postpartum Bleeding · NA · recruiting
- NCT07229573 — The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management · NA · recruiting
- NCT07005349 — THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage · NA · recruiting
Other Samuel Lunenfeld Research Institute, Mount Sinai Hospital trials
Trials by the same sponsor.
- NCT06589687 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery · completed
- NCT06589661 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery · completed
- NCT06368583 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analges · completed
- NCT06368570 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery · completed
- NCT06318715 — Modified Deep Extubation vs. Standard Awake Extubation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02264769 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Last refreshed: 22 May 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02264769.
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