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

ConditionMyoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-45
SponsorWael Elbanna Clinic

About this trial

Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 16-45 years

Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm)

Baseline hemoglobin ≥9 g/dl

No contra-indications to the use of glyopressin or carbitocin

Disqualifiers

Previous myomectomy

History of bleeding disorders

Concurrent anticoagulation therapy

History of Uncontrolled ischaemic heart disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Terlipressin

    Drug

    intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: intracapsular myomectomy Terlipressin injectionActive comparator 1 intervention
Group B: intracapsular myomectomy Carbetocin injectionActive comparator 1 intervention
Group C: intramyometrial salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy

measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy

Time frame
12 hours

Secondary outcomes

1

1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin

compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy

Time frame
24 hours
2

2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time

2\. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy

Time frame
12 hours

Other outcomes

Sponsors and contacts

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