Effect of group counseling versus not counseling on the knowledge, attitude and preference of delivery (prevention of cesarean) in fertile women: a randomized clinical trial
To assess the effect of group counseling versus not counseling on the knowledge, attitude and preference of delivery (prevention of cesarean) in fertile women
Design
This is a randomized clinical trial, phase II, in which 90 eligible fertile women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible fertile women who will refer to Health Centers of Hamadan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 35 years; wiling pregnancy.
Exclusion criteria: infertility; previous history of abortion or pregnancy; mental disease; chronic diseases such as diabetes, cardiovascular diseases, hypertension.
Intervention groups
Intervention group: routine care plus group counseling for 60 minutes weekly for 4 weeks.
Control group: just routine care.
Main outcome variables
Preference of the type of delivery; the knowledge toward the type of delivery; the attitude toward the type of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N239
Registration date:2018-09-29, 1397/07/07
Registration timing:prospective
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling versus not counseling on the knowledge, attitude and preference of delivery (prevention of cesarean) in fertile women: a randomized clinical trial
Public title
Effect of group counseling versus not counseling on the knowledge, attitude and preference of delivery (prevention of cesarean) in fertile women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years old
Wiling pregnancy
Exclusion criteria:
Infertility
A previous history of abortion or pregnancy
Mental disease
Chronic diseases such as diabetes, cardiovascular diseases, hypertension
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.404
Health conditions studied
1
Description of health condition studied
Caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Assessing the preference of the type of delivery
Timepoint
Before intervention and one month after that
Method of measurement
Using a standard questionnaire
2
Description
Assessing the knowledge toward the type of delivery
Timepoint
Before intervention and one month after that
Method of measurement
Using a standard questionnaire
3
Description
Assessing the attitude toward the type of delivery
Timepoint
Before intervention and one month after that
Method of measurement
Using a standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus group counseling for 60 minutes weekly for 4 weeks
Category
Prevention
2
Description
Control group: Just routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Hamadan City
Full name of responsible person
Maryam Ghafari Azandaryani
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m.ghafari@edu.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Ghafari Azandaryani
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m.ghafari@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Masoomi
Position
Fertility Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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