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NCT Number: NCT05242783

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

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.

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Key information

Conditions

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

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wael El-Banna Clinic

Maadi, Cairo Governorate, Egypt

About this study

This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects.

The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

  • Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
  • Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
  • Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets(placebo).

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Terlipressin

Drug

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

Other names: carbitocin, saline (placebo)

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.

    Time frame: 12 hours

    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 )

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.

    Time frame: 24 hours

    • To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. ( to evaluate the change in hemoglobin level between before and after the operation )

Sponsors and collaborators

Lead sponsor

Wael Elbanna Clinic

Other

Registry information

Official study title

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2022
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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