The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbetocin.
- Who it may be relevant to
- Registry conditions: Blood Loss, Surgical. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial of the Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Overview
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
Aim To determine the efficacy of cabetocin in reduction of blood loss during myomectomy.
Specific Objectives To evaluate the impact of cabetocin on prevention of perioperative blood loss during myomectomy.
To assess the transfusion rates, hospital stay, duration of surgery, cadre and years of practice of the surgeon.
To determine if the FIGO stage (Munro, 2011) of the Myoma affect the cabetocin effect.
To assess any intraoperative side effect.
JUSTIFICATION Uterine fibroid - 20%-40% are symptomatic and contribute to subfertility
Hysterectomy has been done for uncontrollable bleeding during myomectomy
Hence, interventions to lessen bleeding during myomectomy and reduce the number of hysterectomy is vital.
Cabetocin is widely recommendation in obstetrics but has limited use in gynaecology; hence the study
STATEMENT OF PROBLEM Myomectomy is associated with significant blood loss and this causes adverse outcomes for patients.
Many haemostatic agents during myomectomy have been explored
However, none has given the desired result.
Cabetocin though, promising in obstetrics practice is yet to be significantly proven in gynaecological practice like myomectomy
METHODOLOGY Multicentre double-blind randomized placebo-controlled trial design
It will be conducted in Ebonyi State across the three tertiary hospitals - (DUFUTH, AEFUTHA and NOFIC)
Comprise women undergoing open abdominal myomectomy who fits into the eligibility criteria.
Following Sample size determination = 300 participants per centre = 900 total participants.
Ethical approvals and support letters from the three centers will be made available
Informed consent will be secured from all participants prior to recruitment.
Participants will be recruited from clinics and surgical outreaches.
Randomization and concealment will be done by the pharmacist.
Normal pre, intra and post op care will be observed as in open myomectomy with 22g tourniquet.
Spinal-Epidural Anesthesia will be used
Group A will receive 100μg intravenous cabetocin at induction of anesthesia
Group B will receive intravenous placebo (normal saline).
Blood loss estimation will follow the method described by Elousov et al.
Preoperative HB done 12hours before the surgery
Postoperative HB done 48hours after the surgery
EBL(liters) = (EBV (Weight in kg x 65ml / 1000) X difference in HB (Hi-Hf) ) / Average HB (Hi-+ Hf) 2 FIGO STAGING OF MYOMA Type 0: Pedunculated intracavitary
Type 1: \<50% intramural extension
Type 2: ≥50% intramural extension
Type 3: 100% intramural, contacting endometrium
Type 4: 100% intramural, zero contact with either the endometrium or the outer serosal surface
Type 5: Subserosal, ≥50% intramural
Type 6: Subserosal, \<50% intramural
Interventions
- Drug Carbetocin
Carbitocin is an oxytocid with longer half life
Primary outcome measures
- Haemoglobin Change [Time frame: 24months]
Secondary outcome measures (1)
- Transfusion rates [Time frame: 24months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07721623 · HREC/17/01/26/01