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

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

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

Study Overview

• Status: Completed
• Conditions: Abdominal Myomectomy
• Intervention / Treatment: Drug: carbetocin 100 mcg; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11231
    • Giza hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: carbetocin; 100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.	Drug: carbetocin 100 mcg; a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
Placebo Comparator: placebo; 10 cm syringe normal saline IV given just before skin incision of myomectomy.	Drug: placebo; a 10 cm syringe normal saline IV given just before skin incision of myomectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean amount of intraoperative blood loss	Mean amount of intraoperative blood loss in ml	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Carbetocin
• Other Study ID Numbers: Myomectomy uterotonic

Drug and device information, study documents

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