Iron requirements increase during pregnancy and it causes risk of developing anemia. The present study aimed to compare the effects of daily, 3–times weekly and weekly regimens on hematological markers in non-anemic pregnant women. Serum ferritin, serum iron and Hb were measured for all pregnant women in their 14th week of gestation who attended the prenatal clinics. Women with Hemoglobin levels less than 11g/dL, chronic hematological disorders (Thalassemia, and etc.) and multiple pregnancies were excluded from the study. A hundred and fifty non-anemic pregnant women in their 16th week period of gestation entered the study. Patients were randomized in three groups and they matched by maternal age, number of pregnancies, income and education. First Group (n=50) received one ferrous sulfate tablet daily, second group (n=50) received 50mg ferrous sulfate tablet three times in a week and finally the third group (n=50) received 100mg ferrous sulfate tablets weekly. Markers were checked again at 28th week of pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101093820N1
Registration date:2011-03-01, 1389/12/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-01, 1389/12/10
Registrant information
Name
Zinatalsadat Bouzari
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4651
Email address
z_b412003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2006-01-01, 1384/10/11
Expected recruitment end date
2008-01-01, 1386/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing three types of iron supplementation in pregnant women
Public title
Iron supplementation in pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Non-anemia pregnant women in their 16th week period of gestation. Exclusion criteria: Women with Hemoglobin levels less than 11g/dL, chronic hematological disorders (Thalassemia, and etc.)
Age
From 17 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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 of Babol University of Medical sciences
Street address
Gangafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
Approval date
2005-11-10, 1384/08/19
Ethics committee reference number
1027
Health conditions studied
1
Description of health condition studied
Iron deficiency anaemia in pregnancy
ICD-10 code
D50.8
ICD-10 code description
Other iron deficiency anaemias
Primary outcomes
1
Description
Hemoglobin
Timepoint
14th week of pregnancy (before iron treatment), 28th week of pregnancy (after iron tretment)
Method of measurement
laboratory
2
Description
Serum iron
Timepoint
14th week of pregnancy (before iron treatment), 28th week of pregnancy (after iron tretment)
Method of measurement
laboratory
3
Description
Serum ferritin
Timepoint
14th week of pregnancy (before iron treatment), 28th week of pregnancy (after iron tretment)
Method of measurement
laboratory
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
12 week
Method of measurement
Questionnaire
Intervention groups
1
Description
First group :50mg ferrous sulfate tablet daily
Category
Treatment - Drugs
2
Description
Second group: 50mg ferrous sulfate tablet three times in a week
Category
Treatment - Drugs
3
Description
Third group : 100mg ferrous sulfate tablet weekly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol health centers
Full name of responsible person
Dr Zinatossadat Bouzari
Street address
Babol University of Medical Sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr Ali Bijani
Street address
Gangafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol 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
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Dr Zahra Basirat
Position
Associate proffessor
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
z_basirat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Zinatossadat Bouzari
Position
Assistant professor, Department of OB & GYN
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1222 8444
Fax
Email
z_b412003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahla Yazdani
Position
Obstetric & Gynecologist
Other areas of specialty/work
Street address
Roohani hospital
City
Babol
Postal code
Phone
+98 11 1223 8301
Fax
Email
Shahla_yazdani_1348@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)