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

NCT ID: NCT04083625

Last Updated: 2020-04-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-02-20

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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carbetocin

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

Group Type EXPERIMENTAL

carbetocin 100 mcg

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AHMED SAMY

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Giza hospital

Giza, , Egypt

Site Status

Countries

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Egypt

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.

Reference Type DERIVED
PMID: 33461754 (View on PubMed)

Other Identifiers

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Myomectomy uterotonic

Identifier Type: -

Identifier Source: org_study_id

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