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Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial

Sponsor: Mansoura University • ClinicalTrials.gov ID: NCT07636421

Registry updated: 2026-10-09

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Description

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.

Interventions

Carbetocin (Drug)
Carbetocin 100 micrograms (1 mL) IV bolus administered over 1 minute immediately after umbilical cord clamping. Identical administration in both arms.
Oxytocin (Drug)
Oxytocin 10 IU added to 500 mL 0.9% sodium chloride, infused at 83 mL/hour over 4 hours, initiated within 2 minutes of carbetocin bolus. Administered in the combination arm only.
Placebo Saline Infusion (Drug)
500 mL 0.9% sodium chloride infused at 83 mL/hour over 4 hours, initiated within 2 minutes of carbetocin bolus. Visually identical to the active oxytocin infusion. Administered in the monotherapy arm only.

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

Conditions

Postpartum Hemorrhage Uterine Atony Cesarean Section Blood Loss, Surgical

Locations

Qassim University Medical City — Buraidah, Al-Qassim Region, Saudi Arabia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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