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Comparison of effect of self-care education on pregnancy outcome in women with preeclampsia: A randomized clinical trial

Protocol summary

Summary
The aim of this study is effect of self care education on pregnancy outcome in women with preeclampsia. After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into A and B groups. Randomization will be performed using random block sizes of 4. The study is randomized, free placebo. Inclusion criteria: Pregnant women with gestational age more than 20 weeks with gestational hypertension. Exclusion criteria: Twin pregnancy, history of intrauterine growth restriction, congenital malformation, chronic diseases(diabetes, hypertension, cardiovascular, renal, hematologic, thyroid). Sample size: 60 patients are participated in the study with 30 patients in each group. The intervention used in the study: Self care education for 30 minutes to 4 times. Primary outcome: Maternal outcomes in pregnancy period, during and after delivery. Secondary outcome: Neonatal outcomes in pregnancy period, during and after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061128385N1
Registration date: 2016-10-07, 1395/07/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-07, 1395/07/16
Registrant information
Name
Zahra Shams
Name of organization / entity
Shahrood Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 11 3536 4011
Email address
z.shams@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of self-care education on pregnancy outcome in women with preeclampsia: A randomized clinical trial
Public title
The effect of self-care education on pregnancy outcome in women with preeclampsia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational age more than 20 weeks with gestational hypertension Exclusion criteria: Twin pregnancy; history of intrauterine growth restriction; congenital malformation; diabetes; hypertension; cardiovascular disease, renal disease, hematologic disease, thyroid disease)
Age
No age limit
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
Ethics committee of Shahrood University of Medical Sciences
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahrood
Postal code
3613773955
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
IR.SHMU.REC.1394.78

Health conditions studied

1

Description of health condition studied
Pre eclampsia
ICD-10 code
O14.9
ICD-10 code description
Pre-eclampsia, unspecified

Primary outcomes

1

Description
Maternal outcomes
Timepoint
During pregnancy and during and after delivery
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Neonatal outcomes
Timepoint
During pregnancy and during and after delivery
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Self care education for 4 sessions and each session is 30 minutes
Category
Lifestyle

2

Description
Control group: Non use of self care education
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein education, Research and Treatment Center, Shahrood
Full name of responsible person
Dr Mohammad Esmaeil Ajami
Street address
City
Shahrood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Dr Sahebali Manafi
Street address
Shahrood Islamic Azad University, Tehran Blvd, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahroud
Full name of responsible person
Zahra Shams
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
Phone
+98 23 3223 7331
Fax
Email
z.shams@iau-shahrood.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Dr Mohammad Esmaeil Ajami
Position
Gynecologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
Phone
+98 23 3223 7331
Fax
Email
ajamime@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Zahra Shams
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3223 7331
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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