Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

Jordan Leitch

Status and phase: Begins enrollment this month; Phase 4

Conditions: Cesarian Section; Cardiac Ischemia

Treatments: Drug: Carbetocin

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06946589

69135

Details and patient eligibility

About

The goal of this project is to examine the cardiac symptoms and physiologic changes after administration of a reduced dose of carbetocin in participants undergoing elective cesarian section.

• Does reduced dose carbetocin (50mcg) have fewer cardiac side effects than usual dose carbetocin (100mcg) when comparing patient reported symptoms, ECG changes and troponin increases?
• Is there a relationship between patient reported cardiac symptoms after carbetocin administration and subjective measures of cardiac ischemia (ECG changes and troponin increases? Researchers will compare 50mcg of carbetocin to the control group of 100mcg of carbetocin in patients undergoing elective cesarian section.

Participants will:

• Be given 50mcg or 100mcg of carbetocin during cesarian section
• Asked to report cardiac symptoms
• Be assessed for ECG changes and blood loss using standard of practice monitoring
• Have a troponin I blood test completed after delivery

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing elective cesarian section
• Primary and repeat cesarian section

Exclusion criteria

• Prior and current cardiovascular co-morbidities including pre-eclampsia
• BMI greater than 50
• Pre-existing bleeding disorders
• Allergy to carbetocin
• Age under 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

50mcg of Carbetocin

Experimental group

Description:

Participants in this arm will receive 50mcg of carbetocin for post party hemorrhage prophylaxis at the the time of umbilical cord clamping during their cesarian section.

Treatment:

Drug: Carbetocin

100mcg of Carbetocin

Active Comparator group

Description:

Participants in this arm will receive 100mcg of carbetocin for post party hemorrhage prophylaxis at the the time of umbilical cord clamping during their cesarian section.

Treatment:

Drug: Carbetocin