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.

Abstract

Objective: To evaluate the efficacy of carbetocin versus placebo in decreasing intraoperative blood loss and the need for blood transfusion during abdominal myomectomy.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Tertiary university hospital from September 2019 to February 2020.

Patient(s): A total of 138 women with symptomatic leiomyoma who were candidates for abdominal myomectomy (n = 69 in each group).

Intervention(s): We randomized the study participants in a 1:1 ratio to carbetocin and placebo groups. Intravenous 100 μg carbetocin or placebo was administered slowly after induction of anesthesia.

Main outcome measure(s): Intraoperative blood loss, need for blood transfusion, postoperative hemoglobin, operative time, length of hospitalization, and drug side-effects.

Result(s): The baseline characteristics were similar among all groups. Carbetocin had significantly lower intraoperative blood loss compared with placebo (mean difference 184 mL). Hemoglobin level 24 hours after surgery was significantly lower in the placebo group than in the carbetocin group (9.1 ± 0.8 vs. 10.3 ± 0.6 g/dL). Eight women in the carbetocin group needed blood transfusion compared with 17 in placebo group. Operative time, length of hospitalization, and side-effects were similar in both groups.

Conclusion(s): A single preoperative intravenous dose of 100 μg carbetocin is a simple, practical, and effective method of decreasing intraoperative blood loss and the need for blood transfusion during abdominal myomectomy, with tolerable, few, nonsignificant side-effects.

Clinical trial registration number: NCT04083625.

Keywords: Carbetocin; blood loss; hemoglobin; myomectomy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Blood Loss, Surgical / prevention & control*
  • Delayed-Action Preparations / administration & dosage
  • Double-Blind Method
  • Female
  • Humans
  • Leiomyoma / drug therapy
  • Leiomyoma / surgery*
  • Middle Aged
  • Oxytocics / administration & dosage*
  • Oxytocin / administration & dosage
  • Oxytocin / analogs & derivatives*
  • Prospective Studies
  • Treatment Outcome
  • Uterine Myomectomy / adverse effects*
  • Uterine Myomectomy / trends
  • Uterine Neoplasms / drug therapy
  • Uterine Neoplasms / surgery*

Substances

  • Delayed-Action Preparations
  • Oxytocics
  • Oxytocin
  • carbetocin

Associated data

  • ClinicalTrials.gov/NCT04083625