Studying the relationship between neonatal hypothyroidism and using iodine and non iodine containing disinfectants before cesarian section in icteric neonates that refer to clinic of neonates in Valiasr hospital
The purpose of this study is to understand whether neonatal hypothroidism have any relathionship with using iodine containing disinfectants during preparaation for cesarean sectin or not.Inclusion criteria:all the mothers which are delivered during 12 month (case gathering period) in emergency department of Valiasr Hospital
Exclusion criteria:mothers that were applied iodine containing disinfectant and thyroid medications before delivery or neonates that were applied these disinfectants or medications during the study period; mothers or neonates which have a systemic disease; mothers with high risk pregnancies.This is a nonrandomised clinical trial which will perform in Valiasr hospital and for cesarean section preparation for 6 consecutive months we will use povidone iodine and for another 6 consecutive months we will use clorhexidine.We will assayTSH & T4(ELISA) in cord blood and in neonates which will return for evaluating jaundice in 3-5 th days of life.Sample size in each group was estimate 300 cases.If these neonate have hypothyroidism we will assay TSH & T4 in 2 nd and 4 th week and also we will evaluate their mother's throid function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204289568N1
Registration date:2012-07-07, 1391/04/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-07, 1391/04/17
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the relationship between neonatal hypothyroidism and using iodine and non iodine containing disinfectants before cesarian section in icteric neonates that refer to clinic of neonates in Valiasr hospital
Public title
Effect of using iodine containing disinfectant in delivery on neonate's thyroid
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:all the mothers which are delivered during 12 month (case gathering period) in emergency department of Valiasr Hospital
Exclusion criteria:mothers that were applied iodine containing disinfectant and thyroid medications before delivery or neonates that were applied these disinfectants or medications during the study period; mothers or neonates which have a systemic disease; mothers with high risk pregnancies.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical Sciences,ghods St., Keshavarz blv,Tehran, Iran
City
Tehran
Postal code
Approval date
2012-04-15, 1391/01/27
Ethics committee reference number
49274
Health conditions studied
1
Description of health condition studied
neonatal hypothyroidism
ICD-10 code
E03.2
ICD-10 code description
Hypothyroidism due to medicaments and other exogenous substances Use additional external cause code (Chapter XX), if desired, to identify cause.
Primary outcomes
1
Description
neonatal hypothyroidism
Timepoint
one time from cord at birth and another time in clinic
Method of measurement
evaluation in laboratory.Measure:yes/no
Secondary outcomes
empty
Intervention groups
1
Description
Interventiom group:using clorhexidine 4% (a disinfectant without iodine & FDA approved) for 6 consecutive months for preparation of mothers which are candidated for cesarean section
Category
Prevention
2
Description
Control group: using Povidone Iodine(a disinfectant with iodine) for 6 consecutive months for preparation of mothers which are candidated for cesarean section