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NCT Number: NCT05266534

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

Recruiting

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Key information

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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 without using haemostatic tourniquets
  • Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
  • Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets 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 computergenerated 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 Criteri

  • Women aged 16-45 yearsAppropriate 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 (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

Exclusion criteria

  • Open myomectomy using mechanical tourniquet
  • 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

the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Other names: glypressin

Carbetocin

Drug

the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Other names: pabal

Saline

Drug

the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Other names: NaCl 0.9

Primary outcomes

  1. To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets

    Time frame: 12 hours

    the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets

Secondary outcomes

  1. To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets

    Time frame: 24 hours

    To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets

  2. To measure the operative time in each group without using haemostatic tourniquets

    Time frame: 24 hours

    To measure the operative time in each group without using haemostatic tourniquets

  3. to assess the measure the severity of pain using VAS score

    Time frame: 24 hours

    post operative pain VAS score

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa mohammad

CONTACT

[email protected]

01212421260

Wael El Banna

CONTACT

[email protected]

01227760402

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 Without Using Haemostatic Tourniquets.

Acronym: myomectomy

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

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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