the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

Abdominal Myomectomy Clinical Trial

Official title:

the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083625
• Other study ID #: Myomectomy uterotonic
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 20, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

• Age = 25 years and = 50 years

• Pre-operative hemoglobin >10 g/dl

• Ability to understand and the willingness to sign a written informed consent.

• Admissible medical/surgical history

• Five or less symptomatic uterine myomas

• symptomatic stage 3 to 6 fibroids, according to FIGO staging

Exclusion Criteria:

• • Post-menopausal women

• Patients with known bleeding/clotting disorders

• Patients with a history of gynecologic malignancy

• Hypertension.

• Cardiac and Pulmonary diseases.

• History of allergic reactions attributed to carbetocin

Related Conditions & MeSH terms

• Abdominal Myomectomy
• Hemorrhage

Intervention

Drug:
• carbetocin 100 mcg
a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
• placebo
a 10 cm syringe normal saline IV given just before skin incision of myomectomy.

Locations

Country	Name	City	State
Egypt	Giza hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amount of intraoperative blood loss	Mean amount of intraoperative blood loss in ml	intraoperative