Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJordan Leitch
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing elective cesarian section
Primary and repeat cesarian section
Disqualifiers
Prior and current cardiovascular co-morbidities including pre-eclampsia
BMI greater than 50
Pre-existing bleeding disorders
Allergy to carbetocin
Trial design
Design model
Parallel
Treatments tested in this trial
Carbetocin
DrugA uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: 50mcg of CarbetocinExperimental treatment 1 intervention
Group B: 100mcg of CarbetocinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient reported symptoms
Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words
Time frame
within 5 minutes of study drug administrationSecondary outcomes
1
Troponin I levels
Troponin I levels on blood work
Time frame
One day after study drug administration2
ECG: ST segment
Changes to the ST segment on ECG
Time frame
5 minutes after study drug administrationOther outcomes
1
Estimated blood loss during surgery
Recorded from anesthesiologists assessment
Time frame
Within 1 hour of study drug administration2
Surgeons assessment of uterine tone
Assessed as a binary of adequate or not adequate
Time frame
3 minutes after study drug administration3
Hemoglobin change
Assessed as a difference between preoperative and postoperative hemoglobin
Time frame
Preoperatively and one day postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Jordan Leitch
Lead sponsor
Queen's University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: