The purpose of this clinical trial in Alzahra hospital was to assess the effect of eliminating supplemental iron on pregnancy outcome. A total of Nine hundred sixty healthy women in the first trimester of pregnancy with Hb>12 gr/dl and BP<140/90 mmHg were randomized to receive a multivitamin+30 mg elemental iron or multivitamin + placebo tablet daily from 13th weeks until the end of pregnancy. Iron parameters were analyzed at the 1st trimester and before delivery by using ELISA. Monthly Hb and Hct checkup was performed for placebo group and those with Hb<10.5 gr/dl at the end of the 2nd trimester or Hb<11 at the 3rd trimester were excluded from the study. The outcome of pregnancy, incidence of preeclampsia, preterm labor, premature rupture of membranes and neonatal weight were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101115563N1
Registration date:2011-02-24, 1389/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-24, 1389/12/05
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2005-09-23, 1384/07/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplemental iron elimination on pregnancy outcome
Public title
The effect of supplemental iron elimination on pregnancy outcome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women who were at the first trimester of pregnancy with single fetus, Hb > 12 gr/dl, not receiving iron containing supplements in the last month, BP < 140/90 mmHg,
Exclusion criteria: Hb less than 10.5 gr/dl or less than 11 gr/dl at the end of 2nd and 3rd trimesters respectively, miscarriage of current pregnancy, abnormality of the fetus, loss to follow-up
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:
960
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht Ave.
City
Tabriz
Postal code
Approval date
2005-07-19, 1384/04/28
Ethics committee reference number
5/4/2665
Health conditions studied
1
Description of health condition studied
pregnancy outcome
ICD-10 code
O26.9
ICD-10 code description
Pregnancy-related condition, unspecified
Primary outcomes
1
Description
preeclampsia
Timepoint
before intervention and every month during pregnancy
Method of measurement
blood pressure checking and urine protein test
2
Description
preterm labor
Timepoint
every month after 20 w of pregnancy
Method of measurement
control of uterine contractions and cervical examination
3
Description
PROM
Timepoint
monthly prenatal care
Method of measurement
declaring membrane rupture by patient and nitrazin test
4
Description
neonatal birth weight
Timepoint
immediately after birth
Method of measurement
by precise scale
Secondary outcomes
1
Description
maternal anemia
Timepoint
monthly prenatal care
Method of measurement
Hb,Hct test
Intervention groups
1
Description
Multivitamin, one oral tablet as well as placebo one tablet, daily, from 13th week of pregnancy until delivery
Category
Treatment - Drugs
2
Description
Multivitamin, one oral tablet as well 30 mg elemental iron, daily, from 13th week of pregnancy until delivery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Prenatal Clinic
Full name of responsible person
Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South Artesh Ave., Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Daneshgah St.
City
Tabriz
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Associate prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1554 1221
Fax
Email
elmadarek33@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
associate prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1554 1221
Fax
Email
elmadarek33@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
elmadarek33@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)