Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Myomectomy

Treatments: Drug: vaginal dinoprostone; Drug: intravenous tranexamic acid; Drug: vaginal placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04357002

dinoprostone tranexamic acid

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

intravenous tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: intravenous tranexamic acid

vaginal dinoprostone

Active Comparator group

Description:

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

Treatment:

Drug: vaginal dinoprostone

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: vaginal placebo