View older revisions Content changed at 2020-12-07, 1399/09/17

Protocol summary

Study aim
Effect of low trans‑fatty acid intakes during pregnancy on adverse pregnancy outcomes
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Preeclampsia Gestational diabetes mellitus Low birth weight

General information

Reason for update
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.
Acronym
IRCT registration information
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
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 diet on adverse pregnancy outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
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.
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
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.
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
Province
Tehran
Postal code
1155673970
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
O14
ICD-10 code description
Pre-eclampsia

2

Description of health condition studied
Low birth weight
ICD-10 code
P05.18
ICD-10 code description
Newborn small for gestational age, 2000-2499 grams

3

Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy

Primary outcomes

1

Description
Preeclampsia
Timepoint
28 weeks of pregnancy
Method of measurement
Midwifery questionnaire

Secondary outcomes

1

Description
Gestational diabetes
Timepoint
28 weeks of pregnancy
Method of measurement
Midwifery questionnaire

2

Description
Low birth weight
Timepoint
At birth time
Method of measurement
Measurement with weight of Mark Seka

Intervention groups

1

Description
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.
Category
Prevention

2

Description
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.
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
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Email
alamolhoda.h@gmail.com

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
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Email
alamolhoda.h@gmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

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
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Province
Tehran
Postal code
1155673970
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
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Province
Tehran
Postal code
1155673970
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
Latest degree
Master
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Province
Tehran
Postal code
1155673970
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)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Low trans fatty acid and gestational diabetes mellitus Low trans fatty acid and preeclampsia Low trans fatty acid and low birth weight
When the data will become available and for how long
2018
To whom data/document is available
Public
Under which criteria data/document could be used
No criteria need
From where data/document is obtainable
Physicians Midwifes Health care giver
What processes are involved for a request to access data/document
No processes need
Comments
Loading...