Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma

Phase 3

Completed

• Conditions: Uterine Leiomyoma
• Interventions: Drug: ascorbic acid; Drug: Normal saline

• Registration Number: NCT01715597
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-29
• Study Start: 2012-12
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-28
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• uterine myoma
• be planning to laparoscopic myomectomy
• images ; the number of myoma <4
• images ; the diameter of the largest myoma <9cm

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Exclusion Criteria

• be planning other surgery in addition to laparoscopy
• clinically significant coagulation abnormality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ascorbic acid	ascorbic acid	ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
ascorbic acid	Normal saline	ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
Control	Normal saline	Normal saline 500ml IV infusion for 2hour

Primary Outcome Measures

Name	Time	Method
blood loss	during laparoscopic myomectomy

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Gyeongg-ido, Korea, Republic of