Evaluation of diet in pregnant women Blood pressure on pregnancy outcomes.
Design
The clinical trial is divided into control and intervention groups, which are two-way blind and are performed on seventy pregnant patients with hypertension. Excel software is used to randomize it.
Settings and conduct
The present study is a double-blind clinical trial on patients with hypertension (who will be on a blood pressure-stopping diet or a normal 2-month diet) and the evaluation of patients by a physician who does not know the patient grouping and They are monitored weekly and will be performed at Imam Khomeini Hospital in Ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant patient with a history of hypertension and patient satisfaction
Exclusion criteria: no underlying disease and no patient cooperation
Intervention groups
Patients are randomly divided into intervention and control groups.
Intervention group: Pregnant patients with high blood pressure in this group by giving (diet that stops blood pressure) during the last two months of pregnancy.Control group: Patients in this group received a high-fat, low-protein diet during the last two months of pregnancy.
DASH (blood pressure suppressant) diet, which is given to patients with hypertension according to the diet of a nutritionist, which is monitored on a weekly basis.
Main outcome variables
During these 2 months, patients' blood pressure is recorded on a weekly basis and maternal and neonatal complications are assessed after delivery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050458N1
Registration date:2021-05-14, 1400/02/24
Registration timing:prospective
Last update:2021-05-14, 1400/02/24
Update count:0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Mahtab Shariati
Name of organization / entity
Ahwaz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4224 8146
Email address
drmahtab64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-15, 1400/02/25
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of dietary approaches to stop hypertension (DASH) in pregnancy outcomes of pregnant women with hypertension (chronic and pregnancy)
Public title
Evaluation of diet in pregnant women Blood pressure on pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant patient with a history of hypertension
Patient consent to participate in the study
Age over 18 years
Exclusion criteria:
Existence of any underlying disease such as diabetes
Patients from whom it is difficult to obtain information
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups.Assigning patients to study groups It is based on a table of random numbers and the use of a computer Accordingly, patients enter one of the two groups in the last two months of pregnancy.
Random allocation sequences are performed without knowing which treatment regimen the patient is receiving.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention (receiving a blood pressure-stopping diet or normal diet) and evaluation of patients is performed by a physician who does not know the patient grouping.
Also, patients and statistical analyzers of the results will not know about patient grouping.Patients do not know how to group and do not know if the group they are in is a test or a control.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapoor University of Medical Sciences
Street address
Golestan Ave.
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-02-02, 1399/11/14
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.141
Health conditions studied
1
Description of health condition studied
Chronic hypertension and Gestational
ICD-10 code
O13.9
ICD-10 code description
Gestational [pregnancy-induced] hypertension without significant proteinuria, unspecified trimester
2
Description of health condition studied
Chronic hypertension (primary)
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
High Blood Pressure
Timepoint
Before Childbirth
Method of measurement
Mercury Sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Patients with hypertension in the intervention group are given by a dietitian DASH and the evaluation of patients is monitored by a doctor on a weekly basis for two months and the results are analyzed based on a questionnaire.Clinical outcomes such as preeclampsia, eclampsia, preterm delivery, placental abruption, Apgar scores in the first and fifth minutes, neonatal weight, and body mass index are assessed.The DASH diet includes whole grains, fruits, vegetables, low-fat dairy products, fish, poultry, and legumes, and avoids creamy butter.
Category
Treatment - Other
2
Description
Control group: In this group, no special diet is given and only low-fat, high-protein foods are recommended, which are evaluated by a doctor on a weekly basis for two months Clinical outcomes such as preeclampsia, eclampsia, preterm delivery, placental abruption, Apgar scores in the first and fifth minutes, neonatal weight, and body mass index are assessed..
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Imam Khomeini Educational and Medical Center
Full name of responsible person
Mahin Najafian
Street address
Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
drmahtab64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadi Moghadam
Street address
Golestan Ave.
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7548
Email
drmahtab64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Najafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
najafian_m@ajumc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Najafian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3589
Email
najafian_m@ajumc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahtab Shariati
Position
Medical Student(Resident)
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan St
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3338 9635
Email
drmahtabshariati64@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data from this study can be shared after unidentified individuals.
When the data will become available and for how long
Start access from the time the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data of the present study can be used in any situation and anywhere
From where data/document is obtainable
Dr. Mahtab Shariati Email drmahtab64@gmail.com Contact Number: 00989356515905
What processes are involved for a request to access data/document
Upon request of the applicant, the documents and the file that can be published will be emailed immediately after verification.