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

Wael Elbanna Clinic

Status: Enrolling

Conditions: Myoma

Treatments: Drug: Carbetocin; Drug: Terlipressin; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05266534

Elbanna_008

Details and patient eligibility

About

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.

Full description

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

Enrollment: 162 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

162 participants in 3 patient groups, including a placebo group

intramyometrial Terlipressin injection in women undergoing open myomectomy

Active Comparator group

Description:

intramyometrial Terlipressin injection

Treatment:

Drug: Terlipressin

intramyometrial Carbetocin injection in women undergoing open myomectomy

Active Comparator group

Description:

intramyometrial Carbetocin injection

Treatment:

Drug: Carbetocin

intramyometrial saline injection in women undergoing open myomectomy procedure

Placebo Comparator group

Description:

intramyometrial saline injection in women

Treatment:

Drug: Saline