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

ConditionMyoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-40
SponsorWael Elbanna Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Open myomectomy using mechanical tourniquet

Previous myomectomy

History of bleeding disorders

Concurrent anticoagulation therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Terlipressin

    Drug

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

  • Carbetocin

    Drug

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

  • Saline

    Drug

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

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: intramyometrial Terlipressin injection in women undergoing open myomectomyActive comparator 1 intervention
Group B: intramyometrial Carbetocin injection in women undergoing open myomectomyActive comparator 1 intervention
Group C: intramyometrial saline injection in women undergoing open myomectomy procedurePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
12 hours

Secondary outcomes

1

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

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

Time frame
24 hours
2

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

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

Time frame
24 hours
3

to assess the measure the severity of pain using VAS score

post operative pain VAS score

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wael Elbanna Clinic

Lead sponsor

Source ClinicalTrials.gov
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