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The effect of spouses education Classes on quality of life and pregnancy outcomes in primiparous women

Protocol summary

Summary
The aim of this clinical trial, not blinded study was to determine the effect of spouse education classes on quality of life and pregnancy outcomes in primiparous women referred to Shahrekord clinic of Hajar hospital. Pregnant women were allocated randomly by computer soft ware in two control (n=27) and intervention (n=31) groups. Inclusion criteria were primiparous women; gestational age of 20 weeks, and single pregnancy and exclusion criteria were previous history of marriage of man or woman, having psychiatry disorder, and having any pregnancy complication such as preeclampsia , intrauterine fetal death and preterm labor. Educational classes for pregnant women in two intervention and control groups held according to national guideline for physiologic delivery in 8 sessions every two weeks (each session 90 minutes). In intervention group, spouse of pregnant women participated in sessions three and eight concomitant their women. Quality of life questionnaire was completed in two groups before beginning the first session and 3 weeks after the eighth session. In addition, in two groups, pregnancy outcomes such as mother's weight gain, birth weight, type of delivery, gestational age, head circumference and neonatal apgar were assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904092265N3
Registration date: 2013-09-07, 1392/06/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Faranak Safdari Decheshmeh
Name of organization / entity
Shahrekord Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
safdari@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Expected recruitment start date
2011-10-02, 1390/07/10
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spouses education Classes on quality of life and pregnancy outcomes in primiparous women
Public title
The effect of spouses education Classes on quality of life and pregnancy outcomes in primiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Primiparous women; gestational age of 20 weeks and single pregnancy. Exclusion criteria: Previous history of marriage of man or woman; having psychiatry disorder, and having any pregnancy complication such as Preeclampsia, intrauterine fetal death and preterm labor.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
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
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Street address
Aytollah Kashani Street, Shahrekord
City
Shahrekord
Postal code
Approval date
2011-03-13, 1389/12/22
Ethics committee reference number
89-12-5

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of other normal pregnancy

Primary outcomes

1

Description
Quality of life
Timepoint
Before beginning the first session and 3 weeks after the eighth session
Method of measurement
Quality of life questionnaire

2

Description
Pregnancy outcomes
Timepoint
Before beginning the first session and 3 weeks after the eighth session
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Educational classes for pregnant women in control group held according to national guideline for physiologic delivery in 8 sessions every two weeks (each session 90 minutes).
Category
Treatment - Drugs

2

Description
Intervention group: In intervention group, spouse of pregnant women participated in sessions three and eight concomitant their women.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Hajar hospital
Full name of responsible person
Faranak Safdari Decheshmeh
Street address
Hajar hospital, Parastar Street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Aytollah Kashani Street, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
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, Shahrekord University of Medical Sciences
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
Shahrekord University of Medical Sciences
Full name of responsible person
Faranak Safdari Decheshmeh
Position
Lecturer
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
faranaksafdari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Faranak Safdari Decheshmeh
Position
Lecturer
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
faranaksafdari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Faranak Safdari Decheshmeh
Position
Lecturer
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
faranaksafdari@gmail.com
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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