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

NCT ID: NCT01715597

Last Updated: 2017-10-31

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Uterine Leiomyoma

Keywords

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uterine leiomyoma laparoscopic myomectomy intraoperative blood loss ascorbic acid

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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ascorbic acid

ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation

Group Type EXPERIMENTAL

ascorbic acid

Intervention Type DRUG

ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour

Normal saline

Intervention Type DRUG

normal saline 500ml IV

Control

Normal saline 500ml IV infusion for 2hour

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

normal saline 500ml IV

Interventions

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ascorbic acid

ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour

Intervention Type DRUG

Normal saline

normal saline 500ml IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* be planning other surgery in addition to laparoscopy
* clinically significant coagulation abnormality
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kidong Kim

Assistant professor in department of OBGY

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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kiding kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Seoul National University Bundang Hospital

Gyeongg-ido, , South Korea

Site Status

Countries

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South Korea

References

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Lee B, Kim K, Cho HY, Yang EJ, Suh DH, No JH, Lee JR, Hwang JW, Do SH, Kim YB. Effect of intravenous ascorbic acid infusion on blood loss during laparoscopic myomectomy: a randomized, double-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Apr;199:187-91. doi: 10.1016/j.ejogrb.2016.02.014. Epub 2016 Feb 21.

Reference Type DERIVED
PMID: 26946313 (View on PubMed)

Other Identifiers

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SNUBH_GO_016

Identifier Type: -

Identifier Source: org_study_id