Abdominal HysterectomyPhase 3NCT03965637
Intravenous Ascorbic Acid Administration in Hysterectomy
A Phase 3 study testing vitamin C in people with Abdominal Hysterectomy, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
vitamin C or ascorbic acid has known role in tissue repair. due to it's properties(water_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Hysterectomy
- What is being tested?
- vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 23 Aug 2019to 30 Jan 2020
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be 18 years and older
- No smoking
- No history of bleeding disorder
- No history of favism
- No history of uterus, ovary, cervical cancer
Who cannot join
- Need to injection of vasopressor drugs
- Surgeon disagreement
Trial locations and contacts
1 site in 1 country.
Iran1 site
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran
About this study
Official title: Effect of Ascorbic Acid Administration on Intraoperative Blood Loss and Wound Healing in Total Abdominal Hysterectomy
vitamin C or ascorbic acid has known role in tissue repair. due to it's properties(water_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets.
Read the detailed description
In this randomized clinical trial, 1000 mg vitamin C will administrate intravenously a day before surgery and during surgery in patients who undergo abdominal hysterectomy.
- Conditions
- Abdominal Hysterectomy
- Being tested
- vitamin C
- Keywords
- vitamin c, Hysterectomy, bleeding, wound healing, abdominal surgeries
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin CDrug
Also called ascorbic acid
water-soluble vitamin C injection contain of 1000 mg vitamin C that given via intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| vitamin C | Experimental | Intervention patients will be received double dose of Ascorbic acid via intravenous injection Receives: Drug: vitamin C |
| Control | No intervention | Control patients will not be received any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of hemorrhage
volume of hemorrhage during surgery
Measured: During surgery
Secondary outcomes (4)
Hemoglobin value
Hemoglobin value after surgery
Measured: 6 and 24 hours after surgery
wound healing
complications after surgery
Measured: during 2 weeks post surgery
duration of stay in hospital
Length of stay in hospital
Measured: up to 2 weeks post surgery
Infection
Developing infection up to 2 weeks
Measured: up to 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start23 Aug 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
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 Abdominal HysterectomyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
- Investigators
- zahra vahdat shariatpanahi, MD,PhD, Study chair, Associatec professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965637
- Sponsor's protocol ID
- 17912
- Status last verified
- Apr 2020
- First submitted
- 26 May 2019
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farahani-Jam S, Yaghmaei M, Vahdat Shariatpanahi Z. Effect of intravenous ascorbic acid administration on hemorrhage and wound complications in total abdominal hysterectomy: A prospective randomized clinical trial. Clin Nutr ESPEN. 2022 Jun;49:74-78. doi: 10.1016/j.clnesp.2022.03.024. Epub 2022 Mar 26.
PubMed 35623878
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ascorbic Acid Administration on Intraoperative Blood Loss and Wound Healing in Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT03965637
- Acronym / sponsor ID
- 17912
- Conditions
- Abdominal Hysterectomy
- Keywords
- vitamin c, Hysterectomy, bleeding, wound healing, abdominal surgeries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 29 May 2019 (actual)
- 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.
vitamin C or ascorbic acid has known role in tissue repair. due to it's properties(water_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets.
Detailed description
In this randomized clinical trial, 1000 mg vitamin C will administrate intravenously a day before surgery and during surgery in patients who undergo abdominal hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin C | Experimental | Drug: vitamin CIntervention patients will be received double dose of Ascorbic acid via intravenous injection |
| Control | No intervention | –Control patients will not be received any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be 18 years and older
- No smoking
- No history of bleeding disorder
- No history of favism
- No history of uterus, ovary, cervical cancer
Key exclusion criteria (2 listed)
- Need to injection of vasopressor drugs
- Surgeon disagreement
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 |
|---|---|---|
| vitamin CAlso: ascorbic acidwater-soluble vitamin C injection contain of 1000 mg vitamin C that given via intravenous injection | Drug | vitamin C |
Primary outcome
volume of hemorrhage
Time frame: During surgery
volume of hemorrhage during surgery
4 secondary outcomes
Hemoglobin value
Time frame: 6 and 24 hours after surgery
wound healing
Time frame: during 2 weeks post surgery
duration of stay in hospital
Time frame: up to 2 weeks post surgery
Infection
Time frame: up to 2 weeks post surgery
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 4 May 2020.
- Derived from this study: PubMed 35623878Farahani-Jam S, Yaghmaei M, Vahdat Shariatpanahi Z. Effect of intravenous ascorbic acid administration on hemorrhage and wound complications in total abdominal hysterectomy: A prospective randomized clinical trial. Clin Nutr ESPEN. 2022 Jun;49:74-78. doi: 10.1016/j.clnesp.2022.03.024. Epub 2022 Mar 26.
- Individual participant dataSharing planned: No
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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.
zahra vahdat shariatpanahi, MD,PhD study chair
Associatec professor
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 vitamin C in people with Abdominal Hysterectomy, run by Shahid Beheshti University at 1 site in Iran.
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 5 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 4 May 2020. 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 Iran. 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. 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?
volume of hemorrhage (time frame: During surgery). 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 NCT03965637, 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 4 May 2020.