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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01715597
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Kidong Kim, 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.

Condition or disease Intervention/treatment Phase
Uterine Leiomyoma Drug: ascorbic acid Drug: Normal saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
Study Start Date : December 2012
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Vitamin C

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

Primary Outcome Measures :
  1. blood loss [ Time Frame: during laparoscopic myomectomy ]

Other Outcome Measures:
  1. time of operation [ Time Frame: during laparoscopic myomectomy ]
  2. the amount of transfusion [ Time Frame: during laparoscopic myomectomy ]
  3. 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)

  4. acute urinary retention [ Time Frame: 2days after the operation ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01715597

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Korea, Republic of
Seoul National University Bundang Hospital
Gyeongg-ido, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: kiding kim, M.D. Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kidong Kim, Assistant professor in department of OBGY, Seoul National University Hospital Identifier: NCT01715597    
Other Study ID Numbers: SNUBH_GO_016
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Keywords provided by Kidong Kim, Seoul National University Hospital:
uterine leiomyoma
laparoscopic myomectomy
intraoperative blood loss
ascorbic acid
Additional relevant MeSH terms:
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Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ascorbic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances