In a randomized, double-blind, placebo-controlled trial, 83 pregnant women with hemoglobin > 13.2 g/dl and ferritin>15μg/l between the 16th and 20th week of pregnancy are randomized into case and control groups. From the 20th week until the end of pregnancy the case group receive one ferrous sulfate tablet containing 50 mg elemental iron daily, while the control group receive placebo. Hemoglobin and ferritin levels at 37-39 weeks of pregnancy are measured and compared. the aim of this study is the relife of pregnancy outcome in pregnant women with high hemoglobin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020612383N1
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Leila Alizadeh niari
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 45 1771 5910
Email address
l_alizadeh@iauardabil.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Ardabil branch.
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2014-09-22, 1393/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of iron supplementation on iron status markers in pregnant women with High Hemoglobin
Public title
The effect of iron supplementation in pregnant women with high hemoglobin
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria were being between 18 and 35 years of maternal age; having a body mass index between 19.8 and 26kg/m2, Hb>13/2g/dl,fr>15μg/l and having a singleton pregnancy.Exclusion criteria were smoking; having a disease related to polycythemia; such as asthma or chronic renal diseases, malignancy and preterm delivery.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad Universiy
Street address
Islamic Azad universiy, Ardabil branch, Basij square, Ardabil
City
Ardabil
Postal code
Approval date
2013-05-27, 1392/03/06
Ethics committee reference number
02-12/1124
Health conditions studied
1
Description of health condition studied
high hemoglobin
ICD-10 code
E90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere
Primary outcomes
1
Description
iron status markers
Timepoint
before intervention, 20 weeks later
Method of measurement
evaluation of hb and ferritin levels
Secondary outcomes
1
Description
anemia
Timepoint
the end of pregnancy
Method of measurement
chek of Hb & ferritin
Intervention groups
1
Description
Iron suplementation in pregnant women with high hemoglobin
Category
Prevention
2
Description
use of plasebo of iron in preganant women with high hemoglobin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal Care Clinics
Full name of responsible person
Agayi Masome
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil branch, Islamic Azad University
Full name of responsible person
Mr Hashemian
Street address
Ardabil branch, Islamic Azad University, Hafez square, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil branch, Islamic Azad University
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
Ardabil branch, Islamic Azad University
Full name of responsible person
Alizadeh Leila
Position
faculty
Other areas of specialty/work
Street address
Ardabil branch, Islamic Azad University, Basij square, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1771 5910
Fax
Email
Alizadehl.ms@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr Mani Ramzi
Position
hematologist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Namazi square, Shiraz, Iran
City
Shiraz
Postal code
Iran
Phone
+98 71 1647 4256
Fax
Email
Ramzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Ardabil Branch
Full name of responsible person
Alizadeh Leila
Position
MS
Other areas of specialty/work
Street address
Islamic Azad University, Ardabil Branch, Basij square, Ardabil, Iran