the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy
NCT ID: NCT04083625
Last Updated: 2020-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
138 participants
INTERVENTIONAL
2019-09-10
2020-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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carbetocin
100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.
carbetocin 100 mcg
a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
placebo
10 cm syringe normal saline IV given just before skin incision of myomectomy.
placebo
a 10 cm syringe normal saline IV given just before skin incision of myomectomy.
Interventions
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carbetocin 100 mcg
a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
placebo
a 10 cm syringe normal saline IV given just before skin incision of myomectomy.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 25 years and ≤ 50 years
* Pre-operative hemoglobin \>10 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* symptomatic stage 3 to 6 fibroids, according to FIGO staging
Exclusion Criteria
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary diseases.
* History of allergic reactions attributed to carbetocin
25 Years
50 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Samy aly ashour
assistant professor
Principal Investigators
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AHMED SAMY
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Giza hospital
Giza, , Egypt
Countries
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References
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Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.
Other Identifiers
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Myomectomy uterotonic
Identifier Type: -
Identifier Source: org_study_id
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