Uterine LeiomyomaPhase 3NCT01715597
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
A Phase 3 study testing ascorbic acid and Normal saline in people with Uterine Leiomyoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Leiomyoma
- What is being tested?
- ascorbic acid and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- uterine myoma
- be planning to laparoscopic myomectomy
- images ; the number of myoma <4
- images ; the diameter of the largest myoma <9cm
Who cannot join
- be planning other surgery in addition to laparoscopy
- clinically significant coagulation abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
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.
- Conditions
- Uterine Leiomyoma
- Being tested
- ascorbic acid, Normal saline
- Keywords
- uterine leiomyoma, laparoscopic myomectomy, intraoperative blood loss, ascorbic acid
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ascorbic acidDrug
ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
Normal salineDrug
normal saline 500ml IV
| Study group | Role | What they receive |
|---|---|---|
| ascorbic acid | Experimental | ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation Receives: Drug: ascorbic acid; Drug: Normal saline |
| Control | Placebo comparator | Normal saline 500ml IV infusion for 2hour Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Measured: during laparoscopic myomectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kidong Kim, Seoul National University Hospital
- Investigators
- kiding kim, M.D., Principal investigator, Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715597
- Sponsor's protocol ID
- SNUBH_GO_016
- Status last verified
- Oct 2017
- First submitted
- 22 Oct 2012
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26946313
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
- ClinicalTrials.gov ID
- NCT01715597
- Acronym / sponsor ID
- SNUBH_GO_016
- Conditions
- Uterine Leiomyoma
- Keywords
- uterine leiomyoma, laparoscopic myomectomy, intraoperative blood loss, ascorbic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ascorbic acid | Experimental | Drug: ascorbic acid, Drug: Normal salineascorbic acid 2g in normal saline 500ml IV start 2hours before the operation |
| Control | Placebo comparator | Drug: Normal salineNormal saline 500ml IV infusion for 2hour |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- uterine myoma
- be planning to laparoscopic myomectomy
- images ; the number of myoma <4
- images ; the diameter of the largest myoma <9cm
Key exclusion criteria (2 listed)
- be planning other surgery in addition to laparoscopy
- clinically significant coagulation abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ascorbic acidascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour | Drug | ascorbic acid |
| Normal salinenormal saline 500ml IV | Drug | Control, ascorbic acid |
Primary outcome
blood loss
Time frame: during laparoscopic myomectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 26946313Lee 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.
Related trials for Uterine Leiomyoma
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kiding kim, M.D. principal investigator
Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ascorbic acid and Normal saline in people with Uterine Leiomyoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: during laparoscopic myomectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.