1. Home
  2. Approved trials
  3. » فارسی

Assessment of the effect of Levothyroxine on the infant development status in pregnant women with autoimmune non overt thyroid disease

Protocol summary

Summary
This study will be conducted in two stages: In the first stage, 1600 pregnant women were evaluated in the first trimester of pregnancy 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 Thyroid peroxidase antibodies (TPOAb) tests. According to the results of the laboratory test, TPOAb positive women (≥50 IU per mL) with TSH >10 μIU per mL in the first 20 weeks of pregnancy is identified as autoimmune non overt thyroid disease and entering the second stage of the study. In the second stage, women with autoimmune non overt thyroid disease with a single pregnancy 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 researcher did not know the sample group when collecting information and completing the questionnaire. The Children developmental status in the two intervention and control groups is examined and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017090414849N6
Registration date: 2017-10-14, 1396/07/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-14, 1396/07/22
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 autoimmune non overt thyroid disease
Public title
The effect of Levothyroxine on the infant development status in pregnant women with autoimmune non overt thyroid disease
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.1395.299

Health conditions studied

1

Description of health condition studied
Thyroid disorders
ICD-10 code
E07.9
ICD-10 code description
Disorder of thyroid, unspecified

Primary outcomes

1

Description
Communication developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)

2

Description
Gross motor 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
Problem solving developmental status
Timepoint
Since 4 months after birth
Method of measurement
Ages and Stages Questionnaire (ASQ)

5

Description
Personal, social 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 a daily dose of 0.5 μg per kg if they have TSH <1.0 μIU per mL, 0.75 μg per kg for TSH between 1.0 and 2.0 μIU per mL, and a 1 μg per kg for TSH >2.0 μIU per mL or a TPOAb titer exceeding 1500 IU per mL. 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

2

Description
There is no intervention for the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Centers under coverage of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Grant for research projects section
Street address
Arabi street, Yaman Avenue, Shahid Chamran Highway, Tehran. Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Sima Nazarpour
Position
PhD, Researcher
Other areas of specialty/work
Street address
No. 24, Arabi street, Yemen street, Velenjak, Tehran, Iran
City
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Fax
Email
snazarpour@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
Gynecologist
Other areas of specialty/work
Street address
No. 24, Arabi street, Yemen street, Velenjak, Tehran, Iran
City
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Fax
Email
fah.tehrani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Sima Nazarpour
Position
PhD, Researcher
Other areas of specialty/work
Street address
No. 24, Arabi street, Yemen street, Velenjak, Tehran, Iran
City
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Fax
Email
snazarpour@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...