Determining the effect of vitamin D administration on the pregnant mother to prevent non-specific respiratory distress
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 3 on 160 patient
Settings and conduct
This study is performed in the gynecology and obstetrics department of Ghaem Hospital in Mashhad. 50000 Unit of vitamin D ampules are injected into the mothers of the group, but there is no additional intervention in the control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pregnant mothers 37-32 weeks with labor symptoms
Non-entry criteria: diabetic mothers, heart disease,Asthma
Excluded Criteria: Infants with obvious congenital anomalies, congenital infections, death in the delivery room, substance abuse by the mother and severe asphyxia, Respiratory distress syndrome, pneumonia, Meconial aspiration syndrom, birth earlier than 4 hours after delivery and later than one week, the need for ventilation in the delivery room
Intervention groups
Intervention group: Pregnant mothers 32-37 weeks with delivery symptoms who use 50,000 units of vitamins D
Control group: Pregnant mothers 32-37 weeks with delivery symptoms who do not use vitamin D
Main outcome variables
Present or absent respiratory distress in the early hours of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110807007244N7
Registration date:2021-02-19, 1399/12/01
Registration timing:registered_while_recruiting
Last update:2021-02-19, 1399/12/01
Update count:0
Registration date
2021-02-19, 1399/12/01
Registrant information
Name
Hassan Boskabadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 515 3987
Email address
boskabadih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D intake in the mother during childbirth on the incidence of nonspecific respiratory distress
Public title
The effect of vitamin D intake in the mother during childbirth on the incidence of respiratory problems in infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant woman with gestational age 32-37 weeks
Exclusion criteria:
Congenital anomaly
Congenital infection
Death of newborn in the delivery room
Severe asphyxia
Mothers with drug abuse
Respiratory distress syndrome
Pneumonia
Transient tachypnea of newborn
Meconium aspiration syndrome
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used as a reliable randomization method that leads to a balanced allocation of individuals in treatment groups at the end of each block. For this purpose, a web-based online method is used to determine the size and number of random blocks.This online software has the ability to create random blocks with variable sizes depending on the researcher.
Using this website, 20 blocks with variable sizes of 6, 8 and 10 are introduced for a total of 160 samples, which are identified by numbers 1 to 20. The content of each block is proportional to the size of that block, including an equal number of intervention and control groups, with the order will be different. Following the first mother, one of the blocks is randomly selected and assigned to one of the groups based on the order of the contents of the block. Following the next mother, the next item of the same block is selected and this process continues until the first block is finished. The next block is selected randomly from the remaining blocks and the above process is repeated until sampling is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The final outcome assessor i.e the researcher who will ultimately evaluate the children in terms of the outcome of the study, is blinded of group allocations
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical Sciences,Ghoraeshi building,Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.613
Health conditions studied
1
Description of health condition studied
Non specific respiratory distress
ICD-10 code
P22.8
ICD-10 code description
Other respiratory distress of newborn
Primary outcomes
1
Description
Present or absent respiratory distress
Timepoint
During the first 12 hours of birth
Method of measurement
Count the number of respiratory rate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Pregnant mothers with a gestational age of 37-32 weeks with delivery symptoms, in four hours to three days before delivery, receive 50,000 units (one sixth of an ampoule) of injectable vitamin D, made by Caspian factory.
Category
Prevention
2
Description
Control group: Pregnant mothers with gestational age 32-37 weeks do not receive intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hassan Boskabadi
Street address
Neonatal Intensive care unite(NICU), Ghaem Hospital, Ahmadabad ST
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
Boskabadih@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research,Ghoraeshi building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Ghaem Hospital, Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
098 5138787109
Email
Boskabadih@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Ghaem Hospital, Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
098 5138412069
Email
Boskabadih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Ghaem Hospital, Ahmadabad ST.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
098 5138787109
Email
Boskabadih@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Effect of vitamin d on NRDS
When the data will become available and for how long
After completing the study
To whom data/document is available
Mashhad University of Medical Sciences Research Vice Chancellor
Under which criteria data/document could be used
According to the research deputy of Mashhad University of Medical Sciences
From where data/document is obtainable
Mashhad University of Medical Sciences Research Vice Chancellor
What processes are involved for a request to access data/document
Request of Mashhad University of Medical Sciences Research Vice Chancellor