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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-06-20

Brief Summary

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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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Detailed Description

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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

Conditions

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Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

double blinded randomized

Study Groups

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intramyometrial Terlipressin injection

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)

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

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

intramyometrial Carbetocin injection

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)

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

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

intramyometrial saline injection

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

Group Type PLACEBO_COMPARATOR

Terlipressin

Intervention Type DRUG

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

Interventions

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Terlipressin

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

Intervention Type DRUG

Other Intervention Names

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carbitocin saline (placebo)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No