The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy

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

Type 7: Pedunculated subserosal

Type 8: Non-myometrial or ectopic

PROFOMA

SERIAL NUMBER:…………………………………….……………………………………………………………. (A) GENERAL CHARACTERISTICS

• Age:………………………………………Parity:……….………….……………………………………………..
• Weight (kg): ........................................ Height (meters):.........................................
• Blood group:…………………………….Rhesus Factor:…………………………………………………. (B) HAEMOGLOBIN ESTIMATION Pre Myomectomy HB:…………………………………………………………………………………………… Post Myomectomy HB:………………………………………………………………………………………….. (C). BLOOD TRANSFUSION RATE:…………………………………………………………………………… (D). DURATION OF HOSPITAL STAY: ............................................................................

(E). CADRE OF THE SURGEON:……………………………………………………………………………….. (F). DURATION OF SURGERY:………………………………………………………………………………….. (G). NOTICED INTRAOPERATIVE SIDE EFFECTS: ……………………………………………………… ………………………………………………………………………………………………………………………………

……………………………………………………………………………………………………………………………… (H). FIGO STAGING OF THE MYOMA:…………………………………………………………………….. (I). DURATION OF SURGERY:………………………………………………………………………………….. (J). NUMBER OF YEARS OF PRACTICE OF THE SURGEON: ……………………………………… (K). PROFESSIONAL CADRE OF THE SURGEON:………………………………………………………

Data will be collected with a profoma and analyzed with SPSS v25.

Continuous variables will be expressed as means ± 2SD, normal distributed data = Student's t-test, and non normal distributed data = Mann-Whitney U test.

Categorical variables will be expressed in frequencies and percentages and compared with Chi-square tests.

A p-value < 0.05 will be considered significant.

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