Skip to main content
OpenTrials
Completed

NCT Number: NCT04083625

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Myomectomy

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Giza hospital

Giza, 11231, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbetocin 100 mcg

Drug

a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.

Placebo

Drug

a 10 cm syringe normal saline IV given just before skin incision of myomectomy.

Primary outcomes

  1. Mean amount of intraoperative blood loss

    Time frame: intraoperative

    Mean amount of intraoperative blood loss in ml

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.