The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:

NCT05242783 | Completed

• 1 other identifier: Elbanna_007
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets.

  To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm )

  12 hours

Secondary Outcomes (1)

• 1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets.

  24 hours

Study Arms (3)

intramyometrial Terlipressin injection

ACTIVE COMPARATOR

intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)

Drug: Terlipressin

intramyometrial Carbetocin injection

ACTIVE COMPARATOR

intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)

Drug: Terlipressin

intramyometrial saline injection

PLACEBO COMPARATOR

intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets. After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural saline as a aplacebo will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) and amount of blood loss and operative time is compared between all arms

Drug: Terlipressin

Interventions

Terlipressin DRUG

intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.

Also known as: carbitocin, saline (placebo)

intramyometrial Carbetocin injection; intramyometrial Terlipressin injection; intramyometrial saline injection

Eligibility Criteria

• Age: 16 Years - 45 Years
• Gender Eligibility Details: women with fibroids undergo open myomectomy using hemostatic tournique
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged 16-45 years
• Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
• Baseline hemoglobin ≥9 g/dl
• No contra-indications to the use of glyopressin or carbitocin
• Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
• Not pregnant at the time of presentation

You may not qualify if:

• Previous myomectomy
• History of bleeding disorders
• Concurrent anticoagulation therapy
• History of Uncontrolled ischaemic heart disease
• Any pelvic abnormalities requiring concomitant surgery
• Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
• Inability to understand and provide written informed consent.

Sponsors & Collaborators

• Wael Elbanna Clinic: lead

Study Sites (1)

Wael El-Banna Clinic

Maadi, Cairo Governorate, Egypt

Location

Related Publications (2)

• Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. Use of vasopressin vs epinephrine to reduce haemorrhage during myomectomy: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:177-181. doi: 10.1016/j.ejogrb.2015.10.003. Epub 2015 Oct 24.

  PMID: 26550945 BACKGROUND

• Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1113. doi: 10.1016/j.jmig.2018.04.008. Epub 2018 Apr 18. No abstract available.

  PMID: 29679676 RESULT

Related Links

• Related Info
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MeSH Terms

Conditions

Myoma

Interventions

Terlipressin; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 16, 2022
• Study Start: February 1, 2022
• Primary Completion: March 29, 2024
• Study Completion: June 20, 2024
• Last Updated: June 25, 2024

Record last verified: 2022-02

Locations

EG (1)