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

October 28, 2017 updated by: Kidong Kim, Seoul National University Hospital

Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ascorbic acid
ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
Drug: ascorbic acid
ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
Drug: Normal saline
normal saline 500ml IV
Placebo Comparator: Control
Normal saline 500ml IV infusion for 2hour
Drug: Normal saline
normal saline 500ml IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood loss
Time Frame: during laparoscopic myomectomy
during laparoscopic myomectomy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of operation
Time Frame: during laparoscopic myomectomy
during laparoscopic myomectomy
the amount of transfusion
Time Frame: during laparoscopic myomectomy
during laparoscopic myomectomy
the difference of hemoglobin
Time Frame: postoperative day 1
postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)
postoperative day 1
acute urinary retention
Time Frame: 2days after the operation
2days after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: kiding kim, M.D., Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 28, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_GO_016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Leiomyoma

Clinical Trials on ascorbic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe