Intravenous Ascorbic Acid Administration in Hysterectomy

April 29, 2020 updated by: Zahra Vahdat Shariatpanahi, Shahid Beheshti University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ascorbic acid
No Intervention: Control
Control patients will not be received any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of hemorrhage
Time Frame: During surgery
volume of hemorrhage during surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin value
Time Frame: 6 and 24 hours after surgery
Hemoglobin value after surgery
6 and 24 hours after surgery
wound healing
Time Frame: during 2 weeks post surgery
complications after surgery
during 2 weeks post surgery
duration of stay in hospital
Time Frame: up to 2 weeks post surgery
Length of stay in hospital
up to 2 weeks post surgery
Infection
Time Frame: up to 2 weeks post surgery
Developing infection up to 2 weeks
up to 2 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Investigators

  • Study Chair: zahra vahdat shariatpanahi, MD,PhD, Associatec professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

May 26, 2019

First Submitted That Met QC Criteria

May 26, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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