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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-30

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05242783

Myoma

COMPLETED NA

The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

NCT05154279

Laparoscopic Myomectomy

RECRUITING NA

The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

NCT05170230

Myoma

RECRUITING NA

Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy

NCT06325501

Myoma;Uterus

RECRUITING PHASE3

the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

NCT04083625

Abdominal Myomectomy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blinded Randomized Placebo-Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double Blinded Randomized Placebo-Controlled Trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intramyometrial Terlipressin injection in women undergoing open myomectomy

intramyometrial Terlipressin injection

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

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

intramyometrial Carbetocin injection in women undergoing open myomectomy

intramyometrial Carbetocin injection

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

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

intramyometrial saline injection in women undergoing open myomectomy procedure

intramyometrial saline injection in women

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Terlipressin

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

Intervention Type DRUG

Carbetocin

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

glypressin pabal NaCl 0.9

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No