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Recruiting NCT05266534

NCT05266534 The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

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Clinical Trial Summary
NCT ID NCT05266534
Status Recruiting
Phase
Sponsor Wael Elbanna Clinic
Condition Myoma
Study Type INTERVENTIONAL
Enrollment 162 participants
Start Date 2021-12-30
Primary Completion 2024-06-30

Eligibility & Interventions

Sex Female only
Min Age 16 Years
Max Age 40 Years
Study Type INTERVENTIONAL
Interventions
TerlipressinCarbetocinSaline

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 162 participants in total. It began in 2021-12-30 with a primary completion date of 2024-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

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

Contact & Investigator

Central Contact

Wael El Banna

✉ waelelbanna@drwaelelbanna.com

📞 01227760402

Frequently Asked Questions

Who can join the NCT05266534 clinical trial?

This trial is open to female participants only, aged 16 Years or older, up to 40 Years, studying Myoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05266534 currently recruiting?

Yes, NCT05266534 is actively recruiting participants. Contact the research team at waelelbanna@drwaelelbanna.com for enrollment information.

Where is the NCT05266534 trial being conducted?

This trial is being conducted at Maadi, Egypt.

Who is sponsoring the NCT05266534 clinical trial?

NCT05266534 is sponsored by Wael Elbanna Clinic. The trial plans to enroll 162 participants.

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