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Clinical Trials/NCT07721623
NCT07721623Not yet recruitingPhase 1

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

Alex Ekwueme Federal University Teaching Hospital0 sites900 target enrollmentStarted: August 15, 2026Last updated:
Conditions
Drugs

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

Sponsor
Alex Ekwueme Federal University Teaching Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Darlington-Peter Chibuzor Ugoji

Dr.

Alex Ekwueme Federal University Teaching Hospital

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