Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy

NCT04482959 | Completed Phase 4

• 1 other identifier: MS.20.07.1178
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• intraoperative bleeding amount

  Minimal Bleeding is insufficient to interfere with the operation or with the clarity of vision Moderate Bleeding that obscure the visual field and resolves only with continuous and constant irrigation of the distention media Excessive Bleeding that necessitate intervention other than continuous and constant irrigation of the distention media (e.g. controlled only by increasing the pressure to tamponade the bleeding from myoma bed)

  Time Frame: Start with the first resectoscope myoma cut till withdrawal of hysteroscope through the cervix at the end of the procedure

• • Change in haemoglobin and hematocrit

  • Change in haemoglobin and hematocrit as surrogate measures of haemostatic effect

  Haemoglobin and hematocrit values 24 hours before myomectomy and 24 hour after myomectomy

Secondary Outcomes (3)

• • Operative time

  Start with insertion of hysteroscope through the cervix ends with withdrawal of hysteroscopy through the cervix at the end of the procedure

• • Fluid deficit

  start with insertion of hysteroscope through the cervix ends with withdrawal of hysteroscopy through the cervix at the end pf the procedure

• • The quality of operative view

  start with the first resectoscope myoma cut till the completion of myoma resection

Study Arms (2)

Carbetocin group

EXPERIMENTAL

This group will contain 20 patients having single type 0 or I submucous uterine myomas according to International Federation of Gynecology and Obstetrics classification system with a largest diameter ≤ 4 cm and myometrial free margin of at least 10 mm.After induction of general anesthesia, immediately before the operation, participants will receive either 1 ml of carbetocin (100 mcg/ml) IV over 1 minute.

Drug: Carbetocin

• Control group

PLACEBO COMPARATOR

This group will contain 20 patients having single type 0 or I submucous uterine myomas according to International Federation of Gynecology and Obstetrics classification system with a largest diameter ≤ 4 cm and myometrial free margin of at least 10 mm.After induction of general anesthesia, immediately before the operation, participants will receive either 1 ml of sodium chloride 0.9% IV over 1 minute.

Drug: Sodium chloride 0.9%

Interventions

Carbetocin DRUG

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

Carbetocin group

Sodium chloride 0.9% DRUG

Physiological solution will be used as placebo

• Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

Related Publications (5)

• Neuwirth RS, Amin HK. Excision of submucus fibroids with hysteroscopic control. Am J Obstet Gynecol. 1976 Sep 1;126(1):95-9. doi: 10.1016/0002-9378(76)90471-3.

  PMID: 961753 RESULT

• Di Spiezio Sardo A, Mazzon I, Bramante S, Bettocchi S, Bifulco G, Guida M, Nappi C. Hysteroscopic myomectomy: a comprehensive review of surgical techniques. Hum Reprod Update. 2008 Mar-Apr;14(2):101-19. doi: 10.1093/humupd/dmm041. Epub 2007 Dec 6.

  PMID: 18063608 RESULT

• Deutsch A, Sasaki KJ, Cholkeri-Singh A. Resectoscopic Surgery for Polyps and Myomas: A Review of the Literature. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1104-1110. doi: 10.1016/j.jmig.2017.08.645. Epub 2017 Aug 24.

  PMID: 28843536 RESULT

• Malm M, Madsen I, Kjellstrom J. Development and stability of a heat-stable formulation of carbetocin for the prevention of postpartum haemorrhage for use in low and middle-income countries. J Pept Sci. 2018 Jun;24(6):e3082. doi: 10.1002/psc.3082. Epub 2018 Apr 27.

  PMID: 29700898 RESULT

• Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.

  PMID: 21345435 RESULT

MeSH Terms

Conditions

Myofibroma

Interventions

carbetocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohamed E Taman, MD

  Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomization will be simple and balanced (1:1) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The participants, caregivers and investigators will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Randomized controlled trial (RCT).

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 23, 2020
• Study Start: July 15, 2020
• Primary Completion: December 30, 2021
• Study Completion: February 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)