The aim of this study is to assess the effect of diet with low trans fatty acids content on adverse pregnancy outcomes among pregnant women.
In this study women under7 weeks who received prenatal care in health centers of the Shahid Beheshti University of Medical Sciences with inclusion criteria, after filed the consent form recruited in this study. Subjects were randomly divided two groups;intervention group with intake dietary pattern with trans fatty acids content less than 1% and control group with intake dietary pattern without any change on trans fatty acids content. the number of subjects in every group was 400. For all pregnant women was filled 24 dietary recall questionnaire in three days at the and of 13,25 and 35 weeks of pregnancy. all pregnant women were received prenatal care in health center and were assessed for adverse pregnancy outcomes incidence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092729902N3
Registration date:2016-11-08, 1395/08/18
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Seideh Hanieh Alamolhoda
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
h_alamolhoda@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
common project between Nursing and Midwifery Faculty with Endocrine and Metabolism Research Center of Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low Trans Fatty Acid content diet on adverse pregnancy outcomes
Public title
The effect of low Trans Fatty Acid content diet on adverse pregnancy outcomes among pregnant women who are attending health center of Shahid Beheshti University Of Medical Sciences
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18 -35 years; gestational age under 7 weeks; single pregnancy; prepregnancy body mass index 19-25 kg/m2 : have normal diet; have reading and writing literacy.
Exclusion criteria: fetus abnormality in recent pregnancy; no consume designed diet during study; no pleasure to continue the study; severe pregnancy nausea and vomiting; smoking; alcohol drinking; addict; have chronic disease such as diabetes; hypertension and etc; history of neonate with maternal abnormality; history of recurrent abortion; history of still birth; history of chronic disease in family.
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:
800
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University Of Medical Sciences
Street address
Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran
City
Tehran
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.SBMU.ries.Rec.1394.92
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
014
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
Primary outcomes
1
Description
preeclampsia
Timepoint
28 weeks of pregnancy
Method of measurement
questionnair
Secondary outcomes
1
Description
gestational diabetes
Timepoint
28 weeks of pregnancy
Method of measurement
questioneire
Intervention groups
1
Description
intervention group: dietary pattern with trans fatty content less than 1%
Category
Prevention
2
Description
Control group: dietary pattern with any change on trans fatty acids content
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Seideh Hanieh Alamolhoda
Street address
Taleghani Hospital, Velenjak, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Shahid Beheshti 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
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Seideh Hanieh Alamolhoda
Position
Faculty Member of Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
alamolhoda.h@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Seideh Hanieh Alamolhoda
Position
Faculty Member of Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
alamolhoda.h@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Seideh Hanieh Alamolhoda
Position
Faculty Member of Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
alamolhoha.h@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)