NCT04357015

Brief Summary

the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2020

Shorter than P25 for phase_4

Status
unknown

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

April 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 20, 2020

Last Update Submit

April 20, 2020

Conditions

Myomectomy

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss

    the intraoperative blood loss in ml will be estimated during the procedure

    one hour

Secondary Outcomes (1)

  • need for blood transfusion

    24 hours

Study Arms (3)

intravenous tranexamic acid

EXPERIMENTAL

The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision

Drug: intravenous tranexamic acid

intravenous carbetocin

ACTIVE COMPARATOR

The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision

Drug: intravenous carbetocin

placebo

PLACEBO COMPARATOR

the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision

Drug: placebo

Interventions

intravenous tranexamic acidDRUG

The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision

intravenous tranexamic acid
intravenous carbetocinDRUG

The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision

intravenous carbetocin
placeboDRUG

the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging

You may not qualify if:

  • women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

AHMED SAMY

CONTACT

+201100681167ahmedsamy8233@gmail.com

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 obstetrics and gynecology

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 22, 2020

Study Start

May 1, 2020

Primary Completion

October 10, 2020

Study Completion

October 20, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04