This study will be conducted in two parts:
In the first stage, 1600 pregnant women were evaluated and a questionnaire including demographic characteristics, medical and midwifery history were completed. Also, their thyroid is examined. Blood samples were taken from sera for TSH, T4 , T-uptake and TPOAb tests. According to the results of the laboratory test, TPOAb negative women(<50 IU/mL) with TSH 2.5–10 μIU/mL in The first 20 weeks of pregnancy is identified as sub-clinical hypothyroidism with negative thyroid peroxidase antibodies (TPOAb-) and entering the second stage of the study. In the second stage, women with subclinical hypothyroidism TPOAb- are randomly divided into two groups of intervention and control. The first group is the intervention group that is treated with levothyroxine and the second group does not receive any intervention. Pregnant women are followed to delivery. After delivery, the developmental status of children is evaluated using Ages and Stages Questionnaire (ASQ) completed by parents for each of the five areas of communication, gross motor, Fine motions, problem solving and personal-social skills. The Children developmental status in the two interventions and control groups is examined and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017090314849N5
Registration date:2017-09-11, 1396/06/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Sima Nazarpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 0340
Email address
simanazarpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Levothyroxine on the infant development status in pregnant women with subclinical hypothyroidism
Public title
The effect of Levothyroxine on the infant development status in pregnant women with subclinical hypothyroidism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women during the first 20 weeks of pregnancy.
Exclusion criteria: multiple pregnancy.
Age
From 15 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Research Institute for Endocrine Sciences and Metabolism of Shahid Beheshti Univers
Street address
No.24 Arabi street- Yemen street - Velenjak- Tehran- Iran
City
Tehran
Postal code
1985717413
Approval date
2017-03-01, 1395/12/11
Ethics committee reference number
IR.SBMU.ENDOCRINE.REC.1395.300
Health conditions studied
1
Description of health condition studied
Subclinical hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism
Primary outcomes
1
Description
Gross motor developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)
2
Description
problem solving developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)
3
Description
Fine motor developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)
4
Description
personal - social developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)
5
Description
communication developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will treat with Levoxine (Levothyroxine sodium). These patients will receive 1 mg per kg of body weight daily levothyroxine. Dosages will maintain throughout pregnancy until delivery. In this study are used from Levothyroxine sodium 0.1 mg manufactured by Iran Hormone.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Centers under coverage of Shahid Beheshti University of Medical Sciences (Alghadir, Kahnak, Fardis,
Full name of responsible person
responsible midwife of center
Street address
City
Tehran and Varamin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid BeheshtiUniversity of Medical Sciences