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the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

Primary Purpose

Abdominal Myomectomy

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
carbetocin 100 mcg
placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Myomectomy

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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

Sites / Locations

  • Giza hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

carbetocin

placebo

Arm Description

100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.

10 cm syringe normal saline IV given just before skin incision of myomectomy.

Outcomes

Primary Outcome Measures

Mean amount of intraoperative blood loss
Mean amount of intraoperative blood loss in ml

Secondary Outcome Measures

Full Information

First Posted
September 6, 2019
Last Updated
April 6, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04083625
Brief Title
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy
Official Title
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Myomectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbetocin
Arm Type
Experimental
Arm Description
100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
10 cm syringe normal saline IV given just before skin incision of myomectomy.
Intervention Type
Drug
Intervention Name(s)
carbetocin 100 mcg
Intervention Description
a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
a 10 cm syringe normal saline IV given just before skin incision of myomectomy.
Primary Outcome Measure Information:
Title
Mean amount of intraoperative blood loss
Description
Mean amount of intraoperative blood loss in ml
Time Frame
intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giza hospital
City
Giza
ZIP/Postal Code
11231
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33461754
Citation
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.
Results Reference
derived

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the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

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