Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

NCT ID: NCT04357002

Last Updated: 2020-04-22

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-10-15

Brief Summary

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

Detailed Description

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Conditions

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Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intravenous tranexamic acid

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.

Group Type EXPERIMENTAL

intravenous tranexamic acid

Intervention Type DRUG

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.

vaginal dinoprostone

patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Group Type ACTIVE_COMPARATOR

vaginal dinoprostone

Intervention Type DRUG

patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

placebo

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

Group Type PLACEBO_COMPARATOR

vaginal placebo

Intervention Type DRUG

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

Interventions

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intravenous tranexamic acid

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.

Intervention Type DRUG

vaginal dinoprostone

patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Intervention Type DRUG

vaginal placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* symptomatic fibroids candidate for abdominal myomectomy

Exclusion Criteria

* patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
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 obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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AHMED SAMY

Role: CONTACT

+201100681167

Other Identifiers

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dinoprostone tranexamic acid

Identifier Type: -

Identifier Source: org_study_id

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