Comparison of neonatal health index and anxiety of active and inactive pregnant women with Covid_19
Design
A clinical trial with two groups, non_randomized, controlled, in phases 2 and 3, on at least 50 patients, for at least 4 months.
Settings and conduct
This is done at home without contact with people. Questionnaires are filled out online to determine nutrition and socioeconomic status. Sports activities such as stretching exercises are taught online. After the baby is born, health index information is collected from the medical record.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Getting covid19, No previous abortion, Age between 18 and 35 years, No history of exercise befor pregnancy, Being primiparous, Similar type of physical activity, Similar type of nutrition, Medium socio-economic status
Exclusion criteria: Dissatisfaction of people to participate in the study, Abortion, Death of a pregnant mother
Intervention groups
The effect of exercise such as walking and stretching exercises on pregnant women with Covid19 during pregnancy on their anxiety and neonatal health index
Main outcome variables
Neonatal health index, Anxiety of active and inactive pregnant women with Covid_19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210317050734N1
Registration date:2021-05-03, 1400/02/13
Registration timing:prospective
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Azam Abeshiloo
Name of organization / entity
The University of semnan
Country
Iran (Islamic Republic of)
Phone
+98 21 3372 9767
Email address
azam.abeshiloo@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neonatal health index and anxiety of active and inactive pregnant women with Covid19
Public title
Comparison of neonatal health index and anxiety of active and inactive pregnant women with Covid19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Getting covid19, No previous abortion, Age between 18 and 35 years, No history of exercise befor pregnancy, Being primiparous, Similar type of physical activity, Similar type of nutrition, Medium socio-economic status
Exclusion criteria:
Dissatisfaction of people to participate in the study, Abortion, Death of a pregnant mother
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Being active and inactive in pregnant women means that pregnant women with Covid_19 had or did not engage in physical activity such as stretching or walking during pregnancy and illness. One group with activity and the other group without physical activity and sports.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of semnan University of Medical sciences
Street address
No.24, Unit2, Dariush Musa Re za, Zolfaghari street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1796813461
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
1399.344
Health conditions studied
1
Description of health condition studied
Covid_19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Covid_19
Timepoint
Before intervention and 2, 3, 4 months after the intervention
Method of measurement
Wendenberg pregnancy anxiety questionnaire, Sharki physical activity governor questionnaire, Half_feed frequency questionnaire, Background information questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women with Civic_19 who are physically active during this time. The type and intensity of the exercise is taught. Such as stretching movements and muscle contraction and expansion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Corona Hospital
Full name of responsible person
Azam Abeshiloo
Street address
No.24, Unit2, Dariush Musa Re za, Zolfaghari street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1796813461
Phone
+98 21 3372 9767
Fax
Email
azam.abeshiloo@semnan.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Azam Abeshiloo
Street address
No.24, Unit2, Dariush Musa Re za, Zolfaghari street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1796813461
Phone
+98 21 3372 9767
Email
azam.abeshiloo@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Azam Abeshiloo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Motor behavior. Motor development
Street address
No.24, Unit2, Dariush Musa Re za, Zolfaghari street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1796813461
Phone
098 021 33729767
Email
azam.abeshiloo@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Azan Abeshiloo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Motor behavior, motor development
Street address
No.24, Unit2, Dariush Musa Re za, Zolfaghari street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1796813461
Phone
098 021 33729767
Email
azam.abeshiloo@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Azam Abeshiloo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Motor behavior, Motor development
Street address
No.24, Unit2, Dariush Musa Re za, Zolfaghari street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1796813461
Phone
098 021 33729767
Email
azam.abeshiloo@semnan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available