Objectives: To determine the effects of iron supplement on neonates anthropometric measures in pregnant women with Hb higher than13.2 gr/dl. Inclusion and Exclusioncriteria: age 17-35, Hb higher than 13.2 gr/dl in 13-18 W of pregnancy, single gestation, BMI=19.8-26, no smoking and alcohol, appropriate nutrition. Participants: 676 pregnant women with Hb higher than 13.2 gr/dl. 340 were placed in the case group and 336 in the control group. Intervention: in the case group consumed 1 ferrous sulphate pill containing 50 mg iron per day from the 20th weeks to the end of pregnancy. the control group consumed 1 placebo pill per day from the 20th weeks to the end of pregnancy. Main outcome measures: weight, height, head circumference of neonates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812042558N4
Registration date:2012-08-30, 1391/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-30, 1391/06/09
Registrant information
Name
Esmat Jafarbegloo
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1722 5100
Email address
jafarbegloo@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modarres University
Expected recruitment start date
2004-04-03, 1383/01/15
Expected recruitment end date
2007-09-22, 1386/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of iron supplement on neonates anthropometric measures in pregnant women with Hb higher than13.2 gr/dl
Public title
Effects of iron supplement on neonates anthropometric measures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 17-35; Hb higher than 13.2 gr/dl in 13-18 W of pregnancy; Single gestation; BMI=19.8-26; no smoking and alcohol; appropriate nutrition; Exclusion criteria: history or illness in heart disease; lung disease; kidny disease; gastrointestinal; thyroid; parathyroid; pancreas; diabetes; lupus; hypertension; epilepsy; viral infection; toxoplasmosis; STD; polycytemia vera; history and acute disease of malignancy; hyperemesis; threatened abortion; bleeding in pregnancy.
Age
From 17 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
676
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
Tarbiat Modaress University
Street address
Jalale-Ale-Ahmad ave- Tehran
City
Tehran
Postal code
Approval date
2004-03-16, 1382/12/26
Ethics committee reference number
6230/103
Health conditions studied
1
Description of health condition studied
Neonates Anthropometric Indexes
ICD-10 code
O28
ICD-10 code description
Abnormal haematological finding on antenatal screening of mother 028
Primary outcomes
1
Description
Neonates Anthropometric Indexes
Timepoint
Postpartum
Method of measurement
Medical Records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One ferrous sulphate pill containing 50 mg iron, per day from the 20th weeks to the end of pregnany.
Category
Placebo
2
Description
Control group: One placebo tablet per day from the 20th weeks to the end of pregnancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maryam Hospital
Full name of responsible person
Esmat Jafarbegloo
Street address
Shoosh sq, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Esmat Jafarbegloo
Street address
Jalale-Ale-Ahmad,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modarres 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
Tarbiat Modarres University
Full name of responsible person
Esmat Jafarbegloo
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Jalale-Ale-Ahmad, Tehran
City
Tehran
Postal code
Phone
+98 21 2255 7873
Fax
Email
jafarbegloo_2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Esmat Jafarbegloo
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Jalale-Ale-Ahmad, Tehran
City
Tehran
Postal code
Phone
+98 21 2255 7873
Fax
Email
jafarbegloo_2004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Esmat Jafarbegloo
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Jalale-Ale-Ahmad, Tehran
City
Tehran
Postal code
Phone
Fax
Email
jafarbegloo_2004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)