Pre-eclampsia is a multi-system disorder that clinically by hypertension and proteinuria, with or without symptoms, laboratory results deteriorate, after 20 weeks of gestation. The aim of this study is to effect of Orem self-care model application in management of pre-eclampsia in pregnant women and their fetus' health. The semi- experimental study will carry out on 60 women with preeclampsia in referents to Fatemieh hospital in Hamadan city, Iran. Written informed consent will obtain from all participants. The participants will randomly select to one of two educations (case) and without education (control) groups. Interventions include: understanding the patient about pre-eclampsia, complications of disease, risk factors and the need to avoid them, the use of prescribed medications and regular visits to the doctor. Intervening period is one month. Women and their fetus' health before and after the one month intervention of Orem self-care model will compare with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107216888N2
Registration date:2013-12-20, 1392/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology Faculty of Medical Sciences (School of Nursing and Midwifery)
Expected recruitment start date
2013-09-27, 1392/07/05
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Application of Orem self-care model for the management of pre-eclampsia in pregnant women and their fetus' health
Public title
Effect of Application of Orem self-care model for the management of pre-eclampsia in pregnant women and their fetus' health Fatemieh hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of physician diagnosis of pre-eclampsia ;A lack of underlying cardiovascular disease; Singleton fetus ; Living in Hamadan order to attend; Gestational age over 20 weeks; a primary and higher education; Lack of mental illness.
Exclusion criteria:<15 age >45؛ Diabetes.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
16/35/9/1344
Health conditions studied
1
Description of health condition studied
Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
ICD-10 code
010-016
ICD-10 code description
Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Infant health
Timepoint
After one month intervention
Method of measurement
Questionaire
2
Description
pre-eclampsia management
Timepoint
After one month intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:Three sessions of Orem self-care model education in management of pre-eclampsia, intervention concepts related to hepertention, proteinoria, various aspects of lifestyle and diet will be conducted
Category
Other
2
Description
Control group: With out any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Fatemeh Shobeiri
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
Full name of responsible person
Heidar Tavilani
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0717
Fax
+98 81 1838 0717
Email
fshobeiri @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0717
Fax
+98 81 1838 0717
Email
fshobeiri @yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Masternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0717
Fax
+98 81 1838 0130
Email
fshobeiri @yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)