A Randomized Controlled Trial of the Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 900
- Primary Endpoint
- Haemoglobin Change
Study Overview
Brief Summary
The uterine fibroids are the most common benign tumors found in the female reproductive system. Uterine fibroids commonly cause heavy menstrual periods. The prevalence of uterine fibroids is significantly affecting up to 70-80% of women by the age of 50, with an inconsistent impact on women of African origin. Carbitocin is a synthetic analogue of oxytocin which has a longer half-life than oxytocin. A Cochrane review and meta-analysis studies found that carbitocin reduced the use of additional uterotonics and transfusion. However, few of these studies was done during myomectomy.
Detailed Description
INTRODUCTION The uterine fibroids - heavy bleeding during myomectomy.
The prevalence - 70-80% of women by the age of 50.
Common in black women.
Cabetocin is a synthetic analogue of oxytocin, with a longer half-life than oxytocin.
A Cochrane review and meta-analysis noted that cabetocin reduced the use of additional uterotonics and blood transfusion, with only few during myomectomy and results inconsistent
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Both the participants, investigator and the assessor of the outcomes will be masked.
only the anesthetic that will be administering the drugs or placebo will know the drug
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All consented women booked for myomectomy.
- •No know allergy to Cabetocin.
- •Billed for open abdominal myomectomy.
Exclusion Criteria
- •Declined consent
- •Allergy to Cabetocin
- •Planned for additional uterotonic
- •Prior history of thromboembolism,
- •With bleeding disorders
- •History of renal disease
- •History of liver pathology
- •Chronic anaemia
- •Billed for vaginal or laparoscopic myomectomy
- •Patients received preoperative embolization or Gn-Rh analogue.
- •Type 8: Non-myometrial or ectopic
Outcomes
Primary Outcomes
Haemoglobin Change
Time Frame: 24months
Pre and Post operative Haemoglobin will be compared
Secondary Outcomes
- Transfusion rates(24months)
Investigators
Darlington-Peter Chibuzor Ugoji
Dr.
Alex Ekwueme Federal University Teaching Hospital