NCT07636421 Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
| NCT ID | NCT07636421 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mansoura University |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 332 participants |
| Start Date | 2026-08-08 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 332 participants in total. It began in 2026-08-08 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Carbetocin is an established single-dose uterotonic agent for postpartum hemorrhage prophylaxis at elective cesarean delivery. Despite its proven efficacy, many clinicians routinely add a supplemental oxytocin infusion following carbetocin administration without evidence-based justification. Concurrent oxytocin receptor stimulation may be redundant, counterproductive through receptor desensitization, or incrementally beneficial - a mechanistic uncertainty that remains unresolved in the published literature. Objectives: To determine whether carbetocin monotherapy (100 micrograms IV bolus plus placebo infusion) is non-inferior to carbetocin plus supplemental oxytocin infusion (10 IU over 4 hours) in preventing the need for additional uterotonic agents within 24 hours of elective cesarean delivery. Study Design: Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial with an integrated pilot phase. Phase 1 (Pilot, n=60) establishes local feasibility and event rate. Phase 2 (Full trial, n=332) provides the definitive non-inferiority analysis. Participants: Women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Qassim University Medical City, singleton pregnancy at or beyond 37 weeks, ASA physical status II, preoperative hemoglobin 9 g/dL or more. Interventions: Group C (Monotherapy): Carbetocin 100 micrograms IV bolus plus placebo saline infusion 500 mL over 4 hours. Group C+O (Combination): Carbetocin 100 micrograms IV bolus plus oxytocin 10 IU in 500 mL saline over 4 hours. Primary Outcome: Proportion of patients requiring at least one additional uterotonic agent within 24 hours of delivery. Secondary Outcomes: Quantitative intraoperative blood loss by gravimetric measurement; total 24-hour blood loss; actual blood loss by Gross formula; hemoglobin and hematocrit changes; uterine tone scores by verbal numerical rating scale (0-10) at 2, 5, and 10 minutes; incidence of postpartum hemorrhage; blood transfusion requirement; hemodynamic profiles; adverse effects. Sample Size: 332 patients (166 per group), non-inferiority margin 10 percentage points, one-sided alpha 0.025, 80% power, estimated baseline event rate 10%, with 15% dropout allowance.
Eligibility Criteria
Inclusion Criteria: * Adult women aged 18 to 45 years * Scheduled for elective non-emergency cesarean delivery * Spinal anesthesia planned and administered as the sole anesthetic technique * Singleton pregnancy at gestational age of 37 completed weeks or more * ASA physical status II * Preoperative hemoglobin of 9 g/dL or more * Able to provide written informed consent in Arabic or English Exclusion Criteria: * Emergency or crash cesarean delivery * Placenta previa, placenta accreta spectrum disorder, or other abnormal placentation * Known uterine anomalies likely to impair contractility including fibroids greater than 5 cm, bicornuate or unicornuate uterus * Grand multiparity defined as 5 or more previous deliveries * Multiple gestation including twins or higher order * Polyhydramnios defined as amniotic fluid index greater than 24 cm * Prior oxytocin augmentation in current pregnancy for more than 6 hours * Known hypersensitivity to carbetocin, oxytocin, or any formulation excipient * Severe preeclampsia, eclampsia, or HELLP syndrome * Cardiovascular disease including arrhythmia, valvular disease, cardiomyopathy, or ischemic heart disease * Known coagulopathy or thrombocytopenia with platelets less than 100 x 10\^9/L * Hepatic or renal impairment * Body mass index greater than 40 kg/m2 at time of delivery * Enrollment in another interventional clinical trial
Contact & Investigator
Mohamed A Tolba, MD
PRINCIPAL INVESTIGATOR
Qassim University Medical City
Frequently Asked Questions
Who can join the NCT07636421 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07636421 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07636421 currently recruiting?
Yes, NCT07636421 is actively recruiting participants. Contact the research team at m_atolba1234@mans.edu.eg for enrollment information.
Where is the NCT07636421 trial being conducted?
This trial is being conducted at Buraidah, Saudi Arabia.
Who is sponsoring the NCT07636421 clinical trial?
NCT07636421 is sponsored by Mansoura University. The principal investigator is Mohamed A Tolba, MD at Qassim University Medical City. The trial plans to enroll 332 participants.