Current partner codePEPTIDESDE
NCT05266534·Not applicable·INTERVENTIONAL

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

Status

Recruiting

Phase

Not applicable

Enrollment

162

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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 detailed 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

Interventions

Treatment arms and agents.

DRUG

Terlipressin

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

DRUG

Carbetocin

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

DRUG

Saline

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

Timeline

From registration to results.

  1. First posted

    Mar 4, 2022

  2. Study start

    Dec 30, 2021

  3. Primary completion

    Jun 30, 2024

  4. Study completion

    Dec 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 4, 2022

Outcomes

What the study measures.

Primary outcomes

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

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

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

to assess the measure the severity of pain using VAS score

Time frame · 24 hours

post operative pain VAS score

Eligibility

Who can take part.

Minimum age
16 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Wael El Banna Clinic

Maadi, Egypt

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

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