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Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy

NCT04482959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-04-06

No results posted yet for this study

Summary

Submucous myomas represent one of the main indications of operative hysteroscopy. Since 1976 when Neuwirth and Amin reported the first five cases of excision of submucous myomas , several techniques have been developed in order to render hysteroscopic myomectomy a safe and effective procedure .

Hysteroscopic myomectomy is currently considered the "gold standard" minimally invasive approach for the treatment of symptomatic submucous myomas . Patients undergoing hysteroscopic myomectomy are liable to significant blood loss, and hemodynamic and hematological disturbances. Excessive bleeding during hysteroscopic myomectomy remains a major challenge for the endoscopic gynecological surgeons. Many interventions were introduced to reduce the risk of bleeding during myomectomy. These include the use of utero-tonics such as oxytocin, or the use of anti-fibrinolytics such as tranexamic acid . The potential advantage of oxytocin infusion during hysteroscopic myomectomy is that it can maintains uterine contractility throughout the procedure, and thus, reduce blood loss .

Carbetocin (1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin. When injected to a woman, it induces uterine contractions . Although many interventions have been described to reduce the intraoperative blood loss during hysteroscopic myomectomy, there is a need for a well-designed randomized controlled trials to identify the most efficient interventions, with reasonable safety profiles, to help the perform a safe and curative surgery.

Conditions

  • Myoma;Uterus

Interventions

DRUG

Carbetocin

(1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin

DRUG

Sodium chloride 0.9%

Physiological solution will be used as placebo

Sponsors & Collaborators

  • Mansoura University Hospital

    lead OTHER

Principal Investigators

  • Mohamed E Taman, MD · Faculty of Medicine - Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-12-30
Completion
2022-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482959 on ClinicalTrials.gov