Protocol summary
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Study aim
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Determining the effect of maternal vitamin D intake during labor on the incidence of transient neonatal tachypnea
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Design
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Clinical trial with control group, parallel groups, single blind, randomized with a sample size of 80 people in any groups
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Settings and conduct
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In the midwifery and maternity ward of the Ghaem hospital of Mashhad, the mothers of the two groups are selected and the intervention group receives vitamin D. The researcher examines the infants without knowing the mothers group and examines them for the presence or absence of Transient Tachypnea of the Newborn.
Vitamin D levels will be measured from mother and baby during delivery.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Mothers with gestational age greater than 32 weeks who have delivery symptoms will be enrolled in the study.
Exclusion criteria: Mothers with asthma
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Intervention groups
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Intervention group: Before delivery, one sixth vial of vitamin D (50,000 units) made by Caspian factory is injected.
Control group: They do not receive vitamin D.
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Main outcome variables
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Transient tachypnea of newborn
General information
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Reason for update
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Dear IRCT Director
Please correct the start and end dates of the project as follows if possible
Thank you
IRCT registration number: IRCT20110807007244N5 Registration date: 2020-07-01, 1399/04/11 Registration timing: retrospective Last update: 2020-07-01, 1399/04/11
Registration date 2020-07-01, 1399/04/11
Expected recruitment start date 2021-01-19, 1399/10/30
Expected recruitment end date 2024-08-29, 1405/04/06
Approval date Ethic: 2020-06-24, 1399/04/04
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110807007244N5
Registration date:
2020-12-01, 1399/09/11
Registration timing:
prospective
Last update:
2026-07-11, 1405/04/20
Update count:
1
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Registration date
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2020-12-01, 1399/09/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-19, 1399/10/30
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Expected recruitment end date
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2024-08-29, 1403/06/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of vitamin d administration during labor on the incidence of Transient Tachypnea of the Newborn
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Public title
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The effect of vitamin d administration during labor on the incidence of Transient rapid breathing of the Newborn
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant mothers upper 32 weeks with delivery symptoms
Exclusion criteria:
Mothers with asthma
Post term pregnancy
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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, using Random Allocation Software, a block randomization list with different sizes 4 or 6 is prepared, then according to the order of the contents of the blocks, which includes the group’s name and unique identification code, each patient is assigned to one of the groups
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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By referring the mother, the midwife accidentally opens one of the blocks and, without knowing the grouping, presents one of the numbers to a researcher who is aware of the type of group. The researcher injects 50000 IU from ampoule of vitamin D into the mother of the intervention group. The infant will be followed up by the principal investigator who is unaware of the type of group, of the presence or absence of transient tachypnea of newborn. Data entry in SPSS is done as groups A and B, and the data analyst is unaware from the intervention or control group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-24, 1399/04/04
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1399.329
Health conditions studied
1
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Description of health condition studied
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Transient Tachypnea of Newborn
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ICD-10 code
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P22.1
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ICD-10 code description
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Transient Tachypnea of Newborn
Primary outcomes
1
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Description
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Frequency of Transient Tachypnea of Newborn
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Timepoint
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1-3 days after neonatal birth
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Method of measurement
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Clinical and radiological signs and clinical course of Transient Tachypnea of Newborn
Intervention groups
1
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Description
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Intervention group: Pregnant mothers with symptoms of labor with a gestational age of more than 32 weeks 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.
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Category
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Prevention
2
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Description
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Control group: Pregnant mothers with labor symptoms with gestational age more than 32 weeks do not receive intervention.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available