Protocol summary

Study aim
Investigating the effect of vitamin C on the amount of bleeding during and after cesarean delivery
Design
A randomized clinical trial with the parallel groups, with control group, double-blind, phase 3 with 30 patients. The block randomization method will be designed by using "www.sealedenvelope.com"
Settings and conduct
This study will be conducted in Kamali Hospital on women scheduled for elective caesarean section .The purpose of this study is to investigate the effect of vitamin C on the amount of bleeding during and after cesarean delivery .Participants will be randomly divided into two groups: one (intravenous injection of vitamin C before cesarean section) and two (no intervention). The participants are aware of the type of intervention, the person who checks the outcome, the surgeon and the statistician are not aware of the type of intervention. The amount of bleeding during and after cesarean section, pain, duration of hospitalization and duration of surgery are compared between two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Candidate for elective cesarean section, age 45-17 Exclusion criteria: Emergency caesarean section, abnormal coagulation test results, Escorbic acid sensitivity , Eyperoxaluria, Creatinine more than 1.5 - UI, Having thalassemia, gout, cystinuria and G6PD deficiency , Oxalate kidney stones and Obesity
Intervention groups
Intervention group: two hours before induction of anesthesia, a vial of vitamin C is injected intravenously from Royan Daro Pharmaceutical Company. Control group: without the use of drugs and intervention
Main outcome variables
The amount of bleeding during and after cesarean section

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221112056479N1
Registration date: 2023-01-08, 1401/10/18
Registration timing: prospective

Last update: 2023-01-08, 1401/10/18
Update count: 0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Zeinab Amirpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
z.amirpour1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of intravenous vitamin C injection during cesarean on the control of bleeding during cesarean and after that in pregnant women candidate for elective cesarean
Public title
Vitamin C in cesarean Effect of vitamin C in bleeding control of cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for elective cesarean section Age 17 to 45 years
Exclusion criteria:
Women who are prepared for caesarean section and other surgery at the same time Emergency caesarean section Abnormal coagulation test Escorbic acid sensitivity Eyperoxaluria Creatinine more than 1.5 - UI Having thalassemia, gout, cystinuria, G6PD deficiency Oxalate kidney stones Obesity
Age
From 17 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation is block and the unit of randomization is individual. The blocked randomization list will be designed using www.sealedenvelope.com. The randomization list will be prepared by the statistician. The treatments will be placed in sealed envelopes according to the block randomization list, which will be kept by the ward nurse who is out of the study. After the patient's eligibility is determined, the procedure is explained to the patient and ethical consent is obtained. Then the nurse provides the envelope containing the type of treatment to the doctor, and the type of treatment is performed based on the treatment in the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistician will be unaware of the intervention method. Because of the type of intervention, the participants know about the type of intervention. Injections are performed by a person who is not part of the operating room staff. As a result, the surgeon and assistant surgeon and the person who records the final result of the study are unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Koi Karmandan North Kocheh 6th West Alley31
City
karaj
Province
Alborz
Postal code
3145746486
Approval date
2022-09-21, 1401/06/30
Ethics committee reference number
IR.ABZUMS.REC.1401.180

Health conditions studied

1

Description of health condition studied
Cesarean section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication

Primary outcomes

1

Description
Bleeding amount
Timepoint
During and 6 and 12 hours after surgery
Method of measurement
Gas number and hemoglobin number (quantitative and qualitative)

Secondary outcomes

1

Description
Pain score
Timepoint
12 hours after cesarean
Method of measurement
Visual analog scale

2

Description
Duration of cesarean section
Timepoint
Immediately after surgery
Method of measurement
Stopwatch

3

Description
Length of hospitalization
Timepoint
At the time of discharge from the hospital
Method of measurement
Patient file

Intervention groups

1

Description
Intervention group: two hours before induction of anesthesia, a vial of vitamin C is injected intravenously from Royan Daro Pharmaceutical Company.
Category
Treatment - Drugs

2

Description
Control group: without the use of drugs and intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Medical Teaching Hospital
Full name of responsible person
zeinab amirpour
Street address
Shahada Square, Esfahani Street
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3240 2161
Email
z.amirpour1371@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
zeinab amirpour
Street address
Taleghani Square, Taleghani BlvdAlborz Urinary Medical Sciences Town
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
z.amirpour1371@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Project implementer
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
zeinab amirpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
The northern employees' bay of Kocheh 6th West
City
karaj
Province
Alborz
Postal code
3145746486
Phone
+98 26 3224 0014
Email
z.amirpour1371@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Bahare khakifirouz
Position
Scientific committee
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karaj, Haft Tir Blvd., Shalchi Alley
City
karaj
Province
Alborz
Postal code
3135663988
Phone
+98 26 3274 4245
Email
bharhkhakyfyrwz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
zeinab amirpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
The northern employees' bay of Kocheh 6th West
City
karaj
Province
Alborz
Postal code
3145746486
Phone
+98 26 3224 0014
Email
z.amirpor1371@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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