Determining the effect of walking on gestational hypertension disorder in women at risk for hypertension referring to midwifery services centers in 1396
Design
Clinical trials with community-based and pragmatic control group, randomized, randomized groups
Settings and conduct
Pregnant women who are prone to gestational hypertension who refer to all of the comprehensive health centers in Rafsanjan, are randomly assigned into two intervention and control groups without any knowledge of which group. The intervention group undergoes a walking intervention from 14 to 34 weeks of pregnancy
Participants/Inclusion and exclusion criteria
inclusion criteria
Pregnancy age 14 weeks
Pregnant women with risk factors for gestational hypertension (history of chronic hypertension, history of gestational hypertension in pregnancy, history of autoimmune disease, apparent diabetes, pregnant mother Nulipar with preeclampsia history in first-degree relatives)
Non-compliance criteria:
Pregnant women who have a limit on physical activity
Pregnant women who have psychological illnesses such as depression and anxiety.
Multiple pregnancy
Do not want to participate in the study
Intervention groups
Pregnant women susceptible to gestational hypertension with a gestational age of 14 to 34 weeks who undergo moderate walking intervention for 20-30 minutes and four times a week.
Control group: no additional work
Main outcome variables
Preeclampsia, preeclampsia added to chronic blood pressure, eclampsia, gestational hypertention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180506039561N1
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Marjan Beigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3432 5810
Email address
beigi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of walking on blood pressure disorders of pregnancy in women susceptible to blood pressure referred to Midwifery Services Provider centers
Public title
The effect of walking on blood pressure disorders of pregnancy in women susceptible to blood pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women are prone to hypertension with gestational age of 14 weeks
Pregnant women with risk factors for gestational hypertension (history of chronic hypertension, history of gestational hypertension in pregnancy, history of autoimmune disease, apparent diabetes, pregnant mother Nulipar with preeclampsia history in first-degree relatives)
Exclusion criteria:
Pregnant women who have a limited physical activity
Pregnant women with a history of psychological illness
Pregnant women with multiple pregnancies
Pregnant women who do not want to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process is performed through a random number table.The researcher selects the numbers from the upper side and considers the pair numbers for the intervention group and the individual numbers for the control group. Also, the process of this sequence is hidden.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hezar jarib . Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
396533
Health conditions studied
1
Description of health condition studied
pregnancy hypertention disorders
ICD-10 code
O10
ICD-10 code description
Pre-existing hypertension complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Types of Pregnancy Blood Pressure (preeclampsia, preeclampsia added to chronic blood pressure, eclampsia, pregnancy blood pressure)
Timepoint
14, 16, 20, 24, 28, 30, 32, 34 weeks of Pregnancy
Method of measurement
Pressure gauge device, clinical and paraclinical findings
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Walking from 14 to 34 weeks of pregnancy four times a week for 20-30 minutes with moderate intensity
Category
Prevention
2
Description
Control group: Without doing extra work
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
All comprehensive health centers and high risk maternity unit of Ali ibn Abitaleb Hospital in Rafsan
Full name of responsible person
Marjan Beigi
Street address
Hezar jarib . Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8138665314
Phone
+98 31 3792 7592
Email
beigi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marjan Beigi
Street address
Hezar jarib . Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8138665314
Phone
+98 31 3792 7592
Email
beigi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marziye loripour
Street address
Emam Ali Blvd . Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
marzeyehloripoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
50
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
Esfahan University of Medical Sciences
Full name of responsible person
Marjan beigi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar Jereb Street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8138665314
Phone
+98 31 3792 7592
Email
beigi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marjan beigi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar Jereb Street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8138665314
Phone
+98 31 3792 7592
Email
beigi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
somaye khoram
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
khoram.somaye@yahoo.com
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
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
These data are provided to comprehensive health centers to advise on the implementation of the walking program by the staff of the centers
When the data will become available and for how long
Start access after the completion of the research project
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Transferring data to comprehensive health center personnel in order to use this plan for pregnant mothers prone to gestational hypertension
From where data/document is obtainable
researchers put it at the disposal of academic researchers
What processes are involved for a request to access data/document
Researchers volunteer to provide data and analysis of information to academic researchers