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

Primary Purpose

Uterine Leiomyoma

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ascorbic acid
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyoma focused on measuring uterine leiomyoma, laparoscopic myomectomy, intraoperative blood loss, ascorbic acid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ascorbic acid

Control

Arm Description

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

Normal saline 500ml IV infusion for 2hour

Outcomes

Primary Outcome Measures

blood loss

Secondary Outcome Measures

Full Information

First Posted
October 22, 2012
Last Updated
October 28, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01715597
Brief Title
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
Official Title
Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyoma
Keywords
uterine leiomyoma, laparoscopic myomectomy, intraoperative blood loss, ascorbic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ascorbic acid
Arm Type
Experimental
Arm Description
ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal saline 500ml IV infusion for 2hour
Intervention Type
Drug
Intervention Name(s)
ascorbic acid
Intervention Description
ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
normal saline 500ml IV
Primary Outcome Measure Information:
Title
blood loss
Time Frame
during laparoscopic myomectomy
Other Pre-specified Outcome Measures:
Title
time of operation
Time Frame
during laparoscopic myomectomy
Title
the amount of transfusion
Time Frame
during laparoscopic myomectomy
Title
the difference of hemoglobin
Description
postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)
Time Frame
postoperative day 1
Title
acute urinary retention
Time Frame
2days after the operation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kiding kim, M.D.
Organizational Affiliation
Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Gyeongg-ido
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26946313
Citation
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.
Results Reference
derived

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

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