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

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Postpartum Hemorrhage, Uterine Atony, Cesarean Section, Blood Loss, Surgical

In brief

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.

Key facts

Study ID: NCT07636421
Run by: Mansoura University
People needed: 332
Starts: 2026-08-01
Expected to finish: 2028-08-01
Last updated by the study team: 2026-06-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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