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Intravenous Ascorbic Acid Administration in Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965637
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Shahid Beheshti University

Brief 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.

Condition or disease Intervention/treatment Phase
Abdominal Hysterectomy Drug: vitamin C Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Ascorbic Acid Administration on Intraoperative Blood Loss and Wound Healing in Total Abdominal Hysterectomy
Actual Study Start Date : August 23, 2019
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vitamin C
Intervention patients will be received double dose of Ascorbic acid via intravenous injection
Drug: vitamin C
water-soluble vitamin C injection contain of 1000 mg vitamin C that given via intravenous injection
Other Name: ascorbic acid

No Intervention: Control
Control patients will not be received any intervention



Primary Outcome Measures :
  1. volume of hemorrhage [ Time Frame: During surgery ]
    volume of hemorrhage during surgery


Secondary Outcome Measures :
  1. Hemoglobin value [ Time Frame: 6 and 24 hours after surgery ]
    Hemoglobin value after surgery

  2. wound healing [ Time Frame: during 2 weeks post surgery ]
    complications after surgery

  3. duration of stay in hospital [ Time Frame: up to 2 weeks post surgery ]
    Length of stay in hospital

  4. Infection [ Time Frame: up to 2 weeks post surgery ]
    Developing infection up to 2 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be 18 years and older
  • No smoking
  • No history of bleeding disorder
  • No history of favism
  • No history of uterus, ovary, cervical cancer

Exclusion Criteria:

  • Need to injection of vasopressor drugs
  • Surgeon disagreement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965637


Locations
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Iran, Islamic Republic of
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Study Chair: zahra vahdat shariatpanahi, MD,PhD Associatec professor
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Responsible Party: Zahra Vahdat Shariatpanahi, Associate Professor, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT03965637    
Other Study ID Numbers: 17912
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zahra Vahdat Shariatpanahi, Shahid Beheshti University:
vitamin c
Hysterectomy
bleeding
wound healing
abdominal surgeries
Additional relevant MeSH terms:
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Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents