Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University Hospital
• Treatments: Carbetocin

Criteria

Inclusion Criteria:

• Symptomatic women aged 18-45 years diagnosed by transvaginal sonography (TVS) to have single type 0 or I submucous uterine myomas according to FIGO classification system with a largest diameter ≤ 4 cm and myometrial free margin of at least 10 mm.

Exclusion Criteria:

• • Age < 18 or > 45 years.

• Uterine septum or structural uterine abnormality (including multiple uterine fibroids and/or multiple submucous myomas)

• Present or history of cervical or uterine malignancies.

• Active pelvic infection.

• Chronic medical diseases (cardiopulmonary, thromboembolic, hepatic, or renal diseases).

• Bleeding disorders.

• Patients receiving anticoagulant therapy.

• Patients receiving gonadotropin-releasing hormone (GnRH) analogues.

• History of adverse reaction contraindications for Carbetocin.