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NCT05266534Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
162 (estimated)
First submitted
21 Dec 2021
Start date
30 Dec 2021
Primary completion date
30 Jun 2024
Lead sponsor
Wael Elbanna Clinic
NCT number
NCT05266534

What you commit to

  • Study type: Interventional
  • Planned participants: 162
  • From 30 Dec 2021 to the primary completion date, 30 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous myomectomy
  • Concurrent anticoagulation therapy
  • Any pelvic abnormalities requiring concomitant surgery
  • Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery

Other illness

  • History of bleeding disorders
  • History of Uncontrolled ischaemic heart disease

Other

  • Open myomectomy using mechanical tourniquet
  • Inability to understand and provide written informed consent

Criteria the registry did not label

  • 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)

Age in the registry: 16 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wael El Banna Clinic
Coordinator of this site? Confirm its status
MaadiEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.