Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Myomectomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04358965

misoprostol myomectomy

Details and patient eligibility

About

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

Enrollment: 162 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic fibroids candidate for abdominal myomectomy

Exclusion criteria

• myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 3 patient groups, including a placebo group

intravenous tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: intravenous tranexamic acid

vaginal misoprostol

Active Comparator group

Description:

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

Treatment:

Drug: vaginal misoprostol

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: placebo