Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2012
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 31, 2017
October 1, 2017
4.8 years
October 22, 2012
October 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood loss
during laparoscopic myomectomy
Other Outcomes (4)
time of operation
during laparoscopic myomectomy
the amount of transfusion
during laparoscopic myomectomy
the difference of hemoglobin
postoperative day 1
- +1 more other outcomes
Study Arms (2)
ascorbic acid
EXPERIMENTALascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
Control
PLACEBO COMPARATORNormal saline 500ml IV infusion for 2hour
Interventions
ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
Eligibility Criteria
You may qualify if:
- uterine myoma
- be planning to laparoscopic myomectomy
- images ; the number of myoma \<4
- images ; the diameter of the largest myoma \<9cm
You may not qualify if:
- be planning other surgery in addition to laparoscopy
- clinically significant coagulation abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Gyeongg-ido, South Korea
Related Publications (1)
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.
PMID: 26946313DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
kiding kim, M.D.
Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor in department of OBGY
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 29, 2012
Study Start
December 1, 2012
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 31, 2017
Record last verified: 2017-10