NCT04358965

Brief Summary

the aim of the present study is to evaluate safety and efficacy of tranexamic acid versus vaginal misoprostol in reducing intraoperative blood loss during abdominal myomectomy

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
162

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 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

May 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 21, 2020

Last Update Submit

April 21, 2020

Conditions

Myomectomy

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss

    intraoperative blood loss will be estimated during open myomectomy in mL

    one hour

Study Arms (3)

intravenous tranexamic acid

EXPERIMENTAL

patients were given a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision plus one vaginal placebo tablet 1 hour before skin incision

Drug: intravenous tranexamic acid

vaginal misoprostol

ACTIVE COMPARATOR

patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Drug: vaginal misoprostol

placebo

PLACEBO COMPARATOR

patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Drug: placebo

Interventions

intravenous tranexamic acidDRUG

patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.

intravenous tranexamic acid
vaginal misoprostolDRUG

patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

vaginal misoprostol
placeboDRUG

patients will be given one vaginal placebo tablet 60 minutes before skin incision and 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:

  • symptomatic fibroids candidate for abdominal myomectomy

You may not qualify if:

  • myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol 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 21, 2020

First Posted

April 24, 2020

Study Start

May 10, 2020

Primary Completion

October 10, 2020

Study Completion

October 30, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04