Determining the Effect of Educational Intervention Program on Postpartum Care on Lifestyle in Preeclamptic Women
Design
randomized trial with two groups
Settings and conduct
Researcher will referr to Alzahra Hospital affiliated to Isfahan University of Medical Sciences.Participants randomly will allocate into two groups.In the intervention group, an designed education program will performed for women with pre eclampsia , and the usual care will taken for the control group
Participants/Inclusion and exclusion criteria
Inclusion criteria are women aged between 15-49 years, Iranian nationality, consent to participate in the study, ability to understand questions or ability to read and write, not participating in any other clinical trials at the same time, no severe mental disorders that requires to be under medical treatment or hospitalization, the nulliparous women with preeclampsia whose delivery resulted in live births.
Intervention groups
Educational intervention consists of 4 sessions of 50 to 60 minutes that will be conducted during the 2 weeks in the form of 3 combined training, lecture, question and answer, group discussion in hospitals and health centers to improve lifestyle in the experimental group. In the control group, routine care is provided.
Main outcome variables
life style
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170927036445N2
Registration date:2018-03-10, 1396/12/19
Registration timing:registered_while_recruiting
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Fatemah Zaremobini
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 7500
Email address
m_kamravamanesh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of a post partum cares educational interventional program for women with preeclampsia
Public title
post partum cares educational program for women with preeclampsia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria are women aged between 15-49 years, Iranian nationality, consent to participate in the study, ability to understand questions or ability to read and write, not participating in any other clinical trials at the same time, no severe mental disorders that requires to be under medical treatment or hospitalization, the nulliparous women with preeclampsia whose delivery resulted in live births.
Exclusion criteria:
The exclusion criterion is not completing the intervention for any reason and being under treatment due to sever complication of preeclampsia, severe life stress , the death of the spouse or immigration and so on .
Age
From 15 years old to 49 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
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random assignment is provided to intervention and control groups with the help of random numbers and one day.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اصفهان
Street address
Hezar jarib Ave,Isfahan, Isfahan University of Medical Sciences,
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.MUI.REC.1395.3.390
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
Pre-eclamp
ICD-10 code description
014
Primary outcomes
1
Description
life style
Timepoint
Before intervention, 1 month later, 3 months after intervention
Method of measurement
life style questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, an interventional educational program designed for women with preeclampsia history.
Category
Lifestyle
2
Description
Control group: the usual care was taken for the control group.