the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy
1 other identifier
interventional
138
1 country
1
Brief Summary
To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedApril 8, 2020
April 1, 2020
5 months
September 6, 2019
April 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean amount of intraoperative blood loss
Mean amount of intraoperative blood loss in ml
intraoperative
Study Arms (2)
carbetocin
EXPERIMENTAL100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.
placebo
PLACEBO COMPARATOR10 cm syringe normal saline IV given just before skin incision of myomectomy.
Interventions
a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
Eligibility Criteria
You may qualify if:
- Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- 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
You may not qualify if:
- Post-menopausal women
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Giza hospital
Giza, 11231, Egypt
Related Publications (1)
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.
PMID: 33461754DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
AHMED SAMY
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
September 6, 2019
First Posted
September 10, 2019
Study Start
September 10, 2019
Primary Completion
February 10, 2020
Study Completion
February 20, 2020
Last Updated
April 8, 2020
Record last verified: 2020-04