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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01715597
Enrollment
50
Registered
2012-10-29
Start date
2012-12-31
Completion date
2017-10-31
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyoma

Keywords

uterine leiomyoma, laparoscopic myomectomy, intraoperative blood loss, ascorbic acid

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.

Interventions

DRUGascorbic acid

ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour

DRUGNormal saline

normal saline 500ml IV

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
blood lossduring laparoscopic myomectomy

Other

MeasureTime frameDescription
time of operationduring laparoscopic myomectomy
the amount of transfusionduring laparoscopic myomectomy
the difference of hemoglobinpostoperative day 1postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)
acute urinary retention2days after the operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026