Protocol summary
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Study aim
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Effect of low trans‑fatty acid intakes during pregnancy on adverse pregnancy outcomes
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Design
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A randomized controlled clinical trial with an intervention group, without blinding, on 800 pregnant women. Latin randomization and Excel software were used for randomization. The intervention group with the received food pattern with the content of trans fatty acids less than 1% and the control group with the received food pattern without change in the content of trans fatty acids.
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Settings and conduct
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This clinical trial study was performed in health centers affiliated to Shahid Beheshti University of Medical Sciences. For pregnant women in intervention group was designed to have a trans fatty acid intake of less than 1%, but this change was not observed in the diet of pregnant women in the control group.
No blinding was performed in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pregnant women with normal pregnancy and gestational age less than 8 weeks
Exclusion criteria: Pregnant women with chronic disease with a history of preeclampsia, gestational diabetes and low birth weight baby
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Intervention groups
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Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake, and in the control group, women received individualized dietary pattern without any focus on trans fatty acids content. Women in control group received individualized dietary pattern without any change in trans fatty acids content.
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Main outcome variables
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Preeclampsia
Gestational diabetes mellitus
Low birth weight
General information
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Reason for update
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The reason for the update is to extract the results of this clinical trial.
This study showed that a diet low in trans fatty acids can reduce the incidence of gestational diabetes, low birth weight and preeclampsia.
Of the 800 women (n=407 in control and n=393 in intervention groups), 108 (13.5%) women were diagnosed with low birth weight. The incidence of low birth weight in intervention group was 12% and in control group was 19%. After multivariable adjustment for confounders, the hazard ratios for incident low birth weight in intervention group were 0.65 (0.44-0.96). Kaplan-Meier plot showed significant difference between two groups in incidence of low birth weight.
There were statistically significant differences in intakes of daily trans fatty acids between the groups (P < 0.05). The hazard ratio (95% CI) for the incidence of preeclampsia in the intervention group was 0.56 (0.33–0.93).
14 women in the intervention group (5%) and 31 women in the control group (8%) were diagnosed with gestational diabetes mellitus. Chi-square test did not show any significant difference between two groups (P=0.08). Cox model was used and the variables were examined in four multivariate models that none of the modals showed a statistically significant difference between the two groups regarding the incidence of GDM.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016092729902N3
Registration date:
2016-11-08, 1395/08/18
Registration timing:
retrospective
Last update:
2020-12-07, 1399/09/17
Update count:
1
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Registration date
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2016-11-08, 1395/08/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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common project between Nursing and Midwifery Faculty with Endocrine and Metabolism Research Center of Shahid Beheshti University Of Medical Sciences
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Expected recruitment start date
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2014-09-23, 1393/07/01
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Expected recruitment end date
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2016-07-22, 1395/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of low Trans Fatty Acid content diet on adverse pregnancy outcomes
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Public title
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The effect of low trans fatty acid diet on adverse pregnancy outcomes
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women aged 18-35 years.
Pregnant women who are less than 7 weeks pregnant.
Pregnant women with singleton pregnancies.
Pre pregnancy body mass index 19-25 kg/m2
Pregnant women who have a pre-pregnancy body mass index of 19-25 kg / m2.
Pregnant women who are literate.
Exclusion criteria:
Diagnose fetal abnormalities in the current pregnancy.
Pregnant women with severe nausea and vomiting during pregnancy.
Pregnant women who smoke.
Pregnant women who drink alcohol.
Pregnant women who are addicted to drugs.
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
800
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Intervention (dietary pattern with trans fatty acids<1%) and control through blocked randomization in block sizes of four and six and with an allocation ratio of 1:1. To conceal the allocation, the type of intervention (dietary pattern with trans fatty acids<1% or routine diet) was written on paper and placed into sequentially numbered opaque envelopes. The researcher opened the envelopes sequentially when a participant entered into the study, and, depending on the type of group written on the paper in the envelope, the participants were allocated to the relevant group. Blocking was done by a person not involved in the sampling.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-05-17, 1395/02/28
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Ethics committee reference number
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IR.SBMU.ries.Rec.1394.92
Health conditions studied
1
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Description of health condition studied
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preeclampsia
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ICD-10 code
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O14
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ICD-10 code description
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Pre-eclampsia
2
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Description of health condition studied
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Low birth weight
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ICD-10 code
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P05.18
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ICD-10 code description
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Newborn small for gestational age, 2000-2499 grams
3
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Description of health condition studied
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Gestational diabetes mellitus
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ICD-10 code
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O24.41
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ICD-10 code description
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Gestational diabetes mellitus in pregnancy
Primary outcomes
1
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Description
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Preeclampsia
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Timepoint
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28 weeks of pregnancy
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Method of measurement
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Midwifery questionnaire
Secondary outcomes
1
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Description
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Gestational diabetes
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Timepoint
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28 weeks of pregnancy
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Method of measurement
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Midwifery questionnaire
2
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Description
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Low birth weight
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Timepoint
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At birth time
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Method of measurement
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Measurement with weight of Mark Seka
Intervention groups
1
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Description
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Intervention group: Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake. we replaced mono- and polyunsaturated fatty acids with free of trans fatty acids in dietary pattern, such as olive oil, fish, nuts, and low fat (1.5%) dairy products, and participants were forbidden to consume the food rich of trans fatty acids such as any kind of fast foods, processed meat, and deep fried foods.
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Category
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Prevention
2
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Description
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women received individualized dietary pattern without any focus on trans fatty acid content. women were allowed to consume any kind of dairy products and oil for cooking and routine dietary recommendation were advised.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Low trans fatty acid and gestational diabetes mellitus
Low trans fatty acid and preeclampsia
Low trans fatty acid and low birth weight
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When the data will become available and for how long
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2018
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To whom data/document is available
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Public
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Under which criteria data/document could be used
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No criteria need
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From where data/document is obtainable
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Physicians
Midwifes
Health care giver
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What processes are involved for a request to access data/document
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No processes need
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Comments
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