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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by Seoul National University Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Kidong Kim, Seoul National University Hospital Identifier:
First received: October 22, 2012
Last updated: December 24, 2013
Last verified: December 2013
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 Intervention Phase
Uterine Leiomyoma
Drug: ascorbic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • blood loss [ Time Frame: during laparoscopic myomectomy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • time of operation [ Time Frame: during laparoscopic myomectomy ] [ Designated as safety issue: No ]
  • the amount of transfusion [ Time Frame: during laparoscopic myomectomy ] [ Designated as safety issue: No ]
  • the difference of hemoglobin [ Time Frame: postoperative day 1 ] [ Designated as safety issue: No ]
    postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)

  • acute urinary retention [ Time Frame: 2days after the operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Control
Normal saline 500ml IV infusion for 2hour


Ages Eligible for Study:   Child, Adult, Senior
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01715597

Contact: Kidong kim, M.D. 82-31-787-7262

Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Gyeongg-ido, Korea, Republic of
Contact: kidong kim, M.D   
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: kiding kim, M.D. Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kidong Kim, Assistant professor in department of OBGY, Seoul National University Hospital Identifier: NCT01715597     History of Changes
Other Study ID Numbers: SNUBH_GO_016 
Study First Received: October 22, 2012
Last Updated: December 24, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
uterine leiomyoma
laparoscopic myomectomy
intraoperative blood loss
ascorbic acid

Additional relevant MeSH terms:
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 processed this record on October 21, 2016