Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

NCT04358965 — Phase 4, Unknown, 162 participants, Cairo University

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Evaluating Safety and Efficacy of Tranexamic Acid Versus Vaginal Misoprostol in Reducing Intraoperative Blood Loss During Abdominal Myomectomy

Registry	NCT04358965
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	162 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Myomectomy
Interventions	intravenous tranexamic acid, vaginal misoprostol, placebo (Drug)
Dates	start 2020-05-10 (estimated), primary completion 2020-10-10 (estimated), completion 2020-10-30 (estimated), first posted 2020-04-24, last updated 2020-04-24

-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

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+Arms and interventions

Arm	Type	Interventions	Description
intravenous tranexamic acid	Experimental	Drug: intravenous tranexamic acid	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
vaginal misoprostol	Active comparator	Drug: vaginal misoprostol	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
placebo	Placebo comparator	Drug: 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

intravenous tranexamic acid (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 misoprostol (Drug): 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
placebo (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

+Outcome measures

Primary outcomes

intraoperative blood loss [one hour]: intraoperative blood loss will be estimated during open myomectomy in mL

+Eligibility

Sex: Female

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

My Notes

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