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NCT03710317
Carbetocin Versus Buccal Misoprostol Plus IV Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section
NA trial testing carbetocin in Cesarean Section Complications in 400 participants. Completed in 1 August 2020.
30 May 2020
Quick facts
| Lead sponsor | Aswan University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 400 |
| Start date | 1 December 2018 |
| Primary completion | 30 May 2020 |
| Estimated completion | 1 August 2020 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- carbetocin (CARBETOCIN) — full drug profile →
- Tranexamic Acid (Tranexamic Acid) — full drug profile →
- misoprostol (Misoprostol) — full drug profile →
Conditions studied
- Cesarean Section Complications — all drugs for Cesarean Section Complications →
Sponsor
Aswan University Hospital
Who can join
Adults 20 to 45, female only, with Cesarean Section Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of postpartum hemorrhage(PPH) in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety. Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much. The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min. A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection. The aim of this study was to compare the effectiveness of combined buccal misoprostol and IV tranexamic acid (TA)with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.
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 NCT03710317
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Related trials
Other trials of carbetocin
Trials testing the same drug.
- NCT03708497 — Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery · NA · completed
- NCT03693599 — Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean · Phase 4 · completed
Other recruiting trials for Cesarean Section Complications
Currently open trials in the same condition.
- NCT07278037 — Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage · recruiting
- NCT05224726 — Platelet Rich Plasma for Uterine Scar · NA · recruiting
- NCT07130747 — Effect of Myofascial Release Versus Deep Friction Massage on Abdominal Recovery and Scar After Cesarean Section · NA · recruiting
- NCT05791630 — The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL) · NA · recruiting
- NCT07049705 — Factors Influencing Bradycardia During Spinal Anesthesia in Obstetric Patients Undergoing Cesarean Section · active not recruiting
Other Aswan University Hospital trials
Trials by the same sponsor.
- NCT06491394 — Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats · Phase 4 · completed
- NCT06211088 — Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting · NA · completed
- NCT06583590 — Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction · Phase 2, PHASE3 · recruiting
- NCT06537323 — Femoral Nerve Block, Periarticular Nerve Group (PENG) Block, and Preoperative IV Fentanyl · NA · recruiting
- NCT06535256 — Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pa · NA · completed
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 NCT03710317 (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 Aswan University Hospital
- Last refreshed: 5 August 2020
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/NCT03710317.
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