Carbetocin Alone vs Carbetocin Plus Oxytocin After Elective Cesarean Delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, non-inferiority trial compares carbetocin monotherapy (100 mcg IV bolus plus placebo) to carbetocin with an oxytocin infusion after elective cesarean delivery. The primary outcome is the need for additional uterotonic medications within 24 hours postpartum. Secondary assessments include intraoperative blood loss and uterine tone measured by a standardized scale, with an integrated pilot phase to establish local feasibility. Eligible participants are women aged 18-45 undergoing elective cesarean delivery with spinal anesthesia and meeting specified health criteria, recruited at Mansoura University with collaboration at Qassim University Medical City. Results could support simplification of uterotonic regimens, reducing drug exposure and nursing workload if monotherapy is non-inferior.

Why it matters

Who can join: the full rules

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

Where it's running

• Qassim University Medical City
  Buraidah, Al-Qassim Region, Saudi Arabia Recruiting

Study contacts

• Principal investigator: Mohamed A Tolba, MD — Qassim University Medical City
• Study coordinator: Mohamed A Tolba, MD
• Email: m_atolba1234@mans.edu.eg
• Phone: 966507439018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.