A clinical trial with community-based control and practice-oriented, double blind, randomized clinical trials
Settings and conduct
The study population was selected from pregnant women with TSH levels between 2.5 to 9.3 in the first trimester and 3 to 1.4 in the second and third trimester of pregnancy referred to Endocrine clinic of Valiasr Hospital in Zanjan.
The method of blindness is done in such a way that the patient returns to the therapist after referral to the center expert and the appointment of A or B group.
Participants/Inclusion and exclusion criteria
Pregnant women with TSH levels ranging from 2.5 to 3.9 in the first trimester; and between 3 to 4.1 in the second and third trimesters; and have no history of spontaneous abortion or previous thyroid disease
Intervention groups
The first group is an intervention group that is treated with levothyroxine tablets at a dose of at least 50 micrograms per day, and the second group, the "control group", does not receive a drug and is only followed up.
Main outcome variables
pregnancy loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180314039091N1
Registration date:2018-05-21, 1397/02/31
Registration timing:registered_while_recruiting
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Farahnaz Mir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 0814
Email address
dr.fa_mir@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using two subclinical hypothyroid treatment approaches during pregnancy on the adverse outcomes of pregnancy
Public title
Effect of TSH Level on adverse Outcome of Pregnancy in Subclinical Hypothyroidism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with TSH levels ranging from 2.5 to 9.3 in the first trimester of pregnancy and TSH levels between 3 to 1.4 in the second and third trimesters
Their free T4 levels are within the normal range
Thyroid size is normal in the examination, and the nodule or mass is not touched
Pregnant women who do not have a history of thyroid disease
Do not have a history of Pregnancy Loss.
There is no history of thyroid surgery
Exclusion criteria:
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A specialist at the Metabolic Disease Research Center, participants randomly divided into two group A and B
Blinding (investigator's opinion)
Double blinded
Blinding description
A specialist at the Metabolic Disease Research Center, participants randomly divided into two groups of control and intervention.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences Ethics Committee
Street address
Metabolic Diseases Research Center, Vali-asr Hospital, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
کدپستی 4515777978
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
ZUMS.REC.1396.225
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
pregnancy Loss
Timepoint
Until 20 weeks for abortion and until delivery for IUFD and Fetal Loss
Method of measurement
check list
2
Description
Eclampsia
Timepoint
During pregnancy care
Method of measurement
Sphygmomanometer
3
Description
neonatal death
Timepoint
Delivery
Method of measurement
check list
4
Description
11/5000Showing translation for آپگار پایینTranslate instead آپکار پائینApgar lower
Timepoint
Delivery
Method of measurement
Apgar score
5
Description
Preterm Labour and Delivery
Timepoint
From 20 to 37 weeks of pregnancy
Method of measurement
Check list
6
Description
Intra Uterim Growth Restrection
Timepoint
During pregnancy
Method of measurement
Ultrasound
7
Description
Premature rupture of membranes
Timepoint
Third Trimsters Pregnancy
Method of measurement
Chek list
8
Description
Placenta previa - premature separation of pelacenta - abruptio placenta
Timepoint
Pregnancy
Method of measurement
Chek list
Secondary outcomes
1
Description
Thyroid hormones(FT4 - T4 - TSH - TOP Ab)
Timepoint
Until the 20th of every month and then at week 32 to 36
Method of measurement
T4 and TSH (ECL method) FT4 and TPO Ab (ICMA method)
Intervention groups
1
Description
Intervention group: Levothyroxine tablets are treated with at least 50 micrograms per day and continue throughout pregnancy until delivery. Patient pills are made by Iranian hormones company.
Category
Treatment - Drugs
2
Description
Control group: They do not receive any drug and they are only under follow up.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Valiasr Hospital in Zanjan
Full name of responsible person
Farahnaz Mir
Street address
Vali-asr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0758
Fax
+98 24 3377 0815
Email
dr.Fa_Mir@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Ali reza Shoghli
Street address
Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0670
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farahnaz Mir
Position
Fellow of Endocrin
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Metabolic Disease Recearch Center, Vali-asr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0814
Fax
+98 24 3377 0815
Email
dr.Fa_Mir@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr hossein Chiti
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Vali-asr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0814
Email
h.chiti@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farahnaz Mir
Position
Flow of the endocrine
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Vali-asr hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0814
Email
dr.Fa_Mir@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD