The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAlex Ekwueme Federal University Teaching Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All consented women booked for myomectomy.

No know allergy to Cabetocin.

Billed for open abdominal myomectomy.

Disqualifiers

Declined consent

Allergy to Cabetocin

Planned for additional uterotonic

Prior history of thromboembolism,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbetocin

    Drug

    Carbitocin is an oxytocid with longer half life

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Carbitocin GroupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Haemoglobin Change

Pre and Post operative Haemoglobin will be compared

Time frame
24months

Secondary outcomes

1

Transfusion rates

The number of units of blood used

Time frame
24months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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