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

What Was Tested

This registered phase 4 trial tested Oxytocin and Carbetocin for post-surgical inflammation and surgery recovery.

It had two arms (groups): Group C - Carbetocin Monotherapy (active comparator) and Group C+O - Carbetocin Plus Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

No published RCT has resolved this uncertainty.

BLOOD LOSS MEASUREMENT: Intraoperative blood loss measured by gravimetric quantification: \[Weight soaked materials minus Weight dry materials\] divided by 1.05, plus suction canister volume, minus irrigation volume, minus amniotic fluid volume.

UTERINE TONE ASSESSMENT: Assessed using the 11-point Verbal Numerical Rating Scale (VNRS 0-10) with predefined anchor definitions, by the blinded operating obstetrician via bimanual palpation at 2, 5, and 10 minutes following carbetocin bolus.

Pre-study inter-rater calibration session with intraclass correlation coefficient target of 0.80 or more.

Who Took Part

Enrollment: 332 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The post-surgical inflammation and surgery recovery participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the post-surgical inflammation and surgery recovery participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-08-08 with completion listed for 2028-04.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Additional Uterotonic Requirement Within 24 Hours (time frame: Within 24 hours of delivery).

It also tracked 11 secondary outcomes, for example Intraoperative Blood Loss - Gravimetric Method, Total 24-Hour Blood Loss, Actual Blood Loss - Gross Formula, Hemoglobin Change, Hematocrit Change and Uterine Tone Score - Verbal Numerical Rating Scale.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 332 people with post-surgical inflammation and surgery recovery.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page and the Carbetocin compound page, Post-surgical inflammation and surgery recovery research.