- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335432
RCT - Efficacy of Intravenous Vitamin C Versus Placebo on Estimated Blood Loss in Total Abdominal Hysterectomy (Vit C in TAH)
Efficacy of Intravenous Vitamin C Versus Placebo on Estimated Blood Loss in Total Abdominal Hysterectomy
Intervention Group: Received two 1 gm doses of Vitamin C intravenously (IV). first Dose: At midnight on the day of surgery. Second Dose: Immediately after the surgical incision. Control Group: Received two doses of a normal saline intravenously (IV) at the exact same times.
The primary outcome was to compare intraoperative blood loss between patients who received intravenous Vitamin C and those who did not, following an abdominal hysterectomy under general anesthesia.
Intraoperative estimated blood loss (EBL) was meticulously quantified by weighing surgical gauze and measuring suction canister volumes.
The secondary outcomes were to evaluate the potential benefits of Vitamin C administration, including:
- Reduction in the decline of hematocrit levels after surgery.
- Reduction of the length of hospital stay
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Changwat Chon Buri
-
Si Racha, Changwat Chon Buri, Thailand, 20110
- Queen Savang Vadhana Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Female patients who underwent total abdominal hysterectomy
- No bleeding tendency.
- No history of anticoagulant or thrombolytic drug use
- No contraindications to vitamin C supplementation
Exclusion Criteria:
Inability to communicate in the Thai language.
- Underwent total abdominal hysterectomy due to gynecologic malignancy.
- Required emergency total abdominal hysterectomy.
- History of vitamin C supplementation within 2 weeks prior to surgery.
- History of smoking.
- Previous abdominal surgery, such as bowel surgery, cesarean section
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Placebo
|
Received two 1 gm doses of Vitamin C intravenously (IV). first Dose: At midnight on the day of surgery. Second Dose: Immediately after the surgical incision. |
|
Experimental: Experimental: Vitamin C
Intervention Group: Received two 1 gm doses of Vitamin C intravenously (IV).
first Dose: At midnight on the day of surgery.
Second Dose: Immediately after the surgical incision.
Control Group: Received two doses of a normal saline intravenously (IV) at the exact same times.
|
Received two 1 gm doses of Vitamin C intravenously (IV). first Dose: At midnight on the day of surgery. Second Dose: Immediately after the surgical incision. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intraoperative estimate blood loss
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Connective Tissue Diseases
- Neoplasms by Histologic Type
- Uterine Diseases
- Genital Diseases, Female
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Connective Tissue
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Adenomyosis
- Hemorrhage
- Myofibroma
- Organic Chemicals
- Carbohydrates
- Sugar Acids
- Acids, Acyclic
- Carboxylic Acids
- Hydroxy Acids
- Ascorbic Acid
Other Study ID Numbers
- 012/2567
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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