The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy

A Randomized Controlled Trial of the Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Carbetocin

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

Type 7: Pedunculated subserosal

Type 8: Non-myometrial or ectopic

PROFOMA

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

1. Age:………………………………………Parity:……….………….……………………………………………..
2. Weight (kg): ........................................ Height (meters):.........................................
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: DARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP; Phone Number: 08068748644; Email: darlingtonpeter2012@gmail.com
• Study Contact Backup: Name: UZOMA MARYROSE AGWU, PROFESSOR; Phone Number: 08033037685; Email: vegorsafeway@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbitocin Group; will receive 100μg intravenous carbetocin at induction of anesthesia	Drug: Carbetocin; Carbitocin is an oxytocid with longer half life; Other Names: Injection water
Placebo Comparator: Placebo group; will receive intravenous placebo (Injection water).	Drug: Carbetocin; Carbitocin is an oxytocid with longer half life; Other Names: Injection water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin Change	Pre and Post operative Haemoglobin will be compared	24months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion rates	The number of units of blood used	24months

Collaborators and Investigators

• Sponsor: Alex Ekwueme Federal University Teaching Hospital
• Investigators: Study Director: DARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP, DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): August 14, 2028

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: blood loss; Carbetocin; Uterotonics; myomectomy.
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Hemorrhage; Blood Loss, Surgical; carbetocin
• Other Study ID Numbers: HREC/17/01/26/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual statistics
• IPD Sharing Time Frame: From January, 2029, for 24month
• IPD Sharing Access Criteria: Will be updated
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No