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Effect of prophylactic iron supplementation on Pregnancy outcome

Protocol summary

Summary
The aim of this double blind clinical trial study is the determination of effect of prophylactic iron supplementation on pregnancy outcome in nonanemic women. One hundred and sixty six nonanemic pregnant women 18-24 years will be divided to 2 groups:1) Supplementation group received 60 mg/d iron as ferrus sulfate2)Control group received placebo .At the beggining, 24-28 weeks and end of the pregnancy hemoglobin, serum ferritin , fasting blood sugar will be measured.Birth Weight, birth height and gestational age will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706141196N1
Registration date: 2008-10-21, 1387/07/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2008-10-21, 1387/07/30
Registrant information
Name
Ebrahim falahi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 422468766198
Email address
e_falahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Deputy of Researches and Technology, Lorestan University of Medical Sciences
Expected recruitment start date
2008-09-06, 1387/06/16
Expected recruitment end date
2008-12-06, 1387/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic iron supplementation on Pregnancy outcome
Public title
Effect of prophylactic iron supplementation on Pregnancy outcome
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: GA: <20 weeks, Age:18-24 y,gravidity 1, BMI:18.5-24.9 kg/m2, Hb>110g/l, Serum Ferritin >20Ug/l Exclusion criteria: Hb<110g/l, infection, disease,
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 166
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
lorestan University of Medical Sciences
Street address
Razi Ave., Deputy of Reseach and technology
City
Khorramabad
Postal code
Approval date
2008-04-30, 1387/02/11
Ethics committee reference number
ت896

Health conditions studied

1

Description of health condition studied
Iron supplementation in pregnant women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
serum ferritin
Timepoint
biggining the study(<20 wk), 28 wk of gestation and 38 wk of gestation
Method of measurement
radioimiunoassay method

2

Description
Hemoglobin
Timepoint
biggining the study(<20 wk), 28 wk of gestation and 38 wk of gestation
Method of measurement
cyanid hemoglobin

3

Description
Fasting blood sugar
Timepoint
biggining the study(<20 wk), 28 wk of gestation and 38 wk of gestation
Method of measurement
Glocose oxidaze

4

Description
birth weight
Timepoint
at birthday
Method of measurement
recording weight by scale

5

Description
birth length
Timepoint
at birthday
Method of measurement
strip meter

6

Description
gestational age
Timepoint
at birthday
Method of measurement
calculated from the number of completed weeks since the first day of the mother's last menstrual period to the date of birth.

Secondary outcomes

1

Description
maternal weight gain
Timepoint
at delivery
Method of measurement
The difference between mothers' weight before pregnancy and after delivery

2

Description
adherence to iron supplementation
Timepoint
at each return visiting by physician
Method of measurement
calculated on the basis of the number of tablets remaining in the box

Intervention groups

1

Description
iron supplementation
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
private office
Full name of responsible person
Dr. Soheila Akbari
Street address
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
lorestan university of medical sciences
Full name of responsible person
Mohamad Hasan Kayedi
Street address
Razi Ave., Deputy of Researches and Technology
City
khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Position
Ph.D in nutrition Sciences-assistant professor
Other areas of specialty/work
Street address
Modiriat boul.,Deputy of Food and Drug
City
Khorramabad
Postal code
Phone
+98 66 1322 4687
Fax
Email
e_falahi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
ebrahim falahi
Position
Assistant Professor and Vice-chancellor of Food and Drug, Ph.D
Other areas of specialty/work
Street address
deputy of food and Drug
City
khorramabad
Postal code
Phone
+98 66 1322 4687
Fax
Email
e_falahi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
lorestan University of Medical sciences
Full name of responsible person
Ebrahim falahi
Position
Ph.D
Other areas of specialty/work
Street address
Deputy of Food and drug
City
Khorramabad
Postal code
Phone
+98 66 1322 4687
Fax
Email
e_falahi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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