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IRCT20110807007244N5 IRCT 2020-12-01 Mashhad University of Medical Sciences The effect of vitamin D administration during labor on the incidence of Transient rapid breathing of the Newborn The effect of vitamin D administration during labor on the incidence of Transient Tachypnea of the Newborn 2020-02-20 anticipated 160 Complete https://irct.ir/trial/45541 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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, 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, Blinding description: 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. 3 Transient tachypnea of newborn. Intervention 1: 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. Intervention 2: Control group: Pregnant mothers with labor symptoms with gestational age more than 32 weeks do not receive intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hassan Boskabadi
NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 91766-99199 00988412069 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences scientific Hassan Boskabadi
NICU, Pediatrics Dep,Ghaem Hospital, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3841 2069 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers upper 32 weeks with delivery symptoms no limit no limit Both Mothers with asthma post term pregnancy P22.1 Transient tachypnea of newborn Prevention Prevention 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. Control group: Pregnant mothers with labor symptoms with gestational age more than 32 weeks do not receive intervention. Frequency of transient tachypnea of newborn. Timepoint: 1-3 days after neonatal birth. Method of measurement: Clinical and radiological signs and clinical course of transient tachypnea of newborn. Mashhad University of Medical Sciences Approved 2020-06-24 Ethics committee of Mashhad University of Medical Sciences Ethics committee,ّ3rd Floor, ghorashi bulding,Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)