This Single Blind RCT evaluates the treatment effects of levothyroxine on reducing pregnancy complications among pregnant women having such antibodies. The pregnant women having thyroid peroxides antibody are randomly divided into two groups. Up to the end of pregnancy period, a daily dose of 50 microgram levothyroxine is prescribed for interventions group. Control group will not receive any treatment. The participants are followed up till the end of pregnancy period and the pregnancy outcomes (Preterm delivery, Abortion and PROM) and embryonic consequences (Apgar and Weight) are assessed and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105316152N2
Registration date:2011-06-19, 1390/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-19, 1390/03/29
Registrant information
Name
Fariba Seyedoshohadaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 82 1328 2001
Email address
f.seyedoshohadaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of levothyroxine therapy in pregnant women with thyroid peroxides antibody on Pregnancy outcomes
Public title
Effect of levothyroxine therapy in pregnant women with thyroid peroxides antibody on Pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: First trimester pregnancy
Exclusion criteria: Thyroid diseases, TSH less than 0.2 or > 4 ng/ml, recurrent abortion (3 consecutive abortions)
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Kurdistan University of Medical Sciences
Street address
Kurdistan University of medical sciences, Pasdaran Ave
City
Sanandaj
Postal code
Approval date
2010-02-03, 1388/11/14
Ethics committee reference number
10576پ14پ
Health conditions studied
1
Description of health condition studied
thyroid peroxides antibody
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
premature delivery
Timepoint
at the end of pregnancy
Method of measurement
observation
Secondary outcomes
1
Description
premature rupture of membrane
Timepoint
at the end of pregnancy
Method of measurement
observation
2
Description
delivery type
Timepoint
at the end of pregnancy
Method of measurement
observation
3
Description
newborn’s Apgar score
Timepoint
at end of pregnancy
Method of measurement
observation
4
Description
newborn’s weight
Timepoint
at the end of pregnancy
Method of measurement
observation
Intervention groups
1
Description
Control group: No treatment
Category
N/A
2
Description
Intervention group: a daily dose of 50 microgram levothyroxine during pregnancy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Fariba Seyedoshohadaei
Street address
Besat Hospital, Keshavarz Ave
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Ataollah Heidari
Street address
Kurdistan University of Medical Sciences, Pasdaran Ave
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Seyedoshohadaei
Position
Associate Prof.
Other areas of specialty/work
Street address
Besat Hospital
City
Sanandaj
Postal code
Phone
+98 87 1328 2001
Fax
Email
f.seyedoshohadaei@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Shahla Nouroozi
Position
Resident
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
Phone
+98 917 183 0378
Fax
Email
dr.nouroozi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)