Protocol summary

Summary
The aim of this study was to investigate the effects of educational message tailoring on pregnant women’s self-efficacy, perceived social support, and intention to choose normal vaginal delivery. Study population consisted of pregnant women who, in 2016, referred to Shahid Avval and Shahid Navvab Safavi community health centers, Isfahan, Iran, for attending prenatal education classes. The main inclusion criteria were a gestational age of 20–25 weeks and no contraindication for normal vaginal delivery while the main exclusion criterion was inability or unwillingness to stay in the study. Women were randomly allocated to a control and an intervention group. Primarily, all women in both groups completed study questionnaires in the first session of the study intervention held in the 20th–25th weeks of their pregnancy. Then, women in the intervention group were provided with a CD containing tailored educational messages on pregnancy and delivery. Messages were provided through PowerPoint presentation files. Women in the control group received no tailored educational messages on pregnancy and delivery. All women in both groups received routine prenatal educations. Women re-completed study questionnaires at the end of the last prenatal education class which coincided with the 37th week of their pregnancy. The time interval between pretest and posttest was four months. The primary outcome was improvements in the knowledge, attitude, self-efficacy, and perceived social support for selecting normal vaginal delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017043033731N1
Registration date: 2017-08-11, 1396/05/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-11, 1396/05/20
Registrant information
Name
khadijeh Mohammadali Makhouli
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3433 6812
Email address
kh.makhouli@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of educational message tailoring on pregnant women’s self-efficacy, perceived social support, and intention to choose normal vaginal delivery
Public title
The role of prenatal education tailoring in the choice of delivery type
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Primigravidas; A gestational age of 20–25 weeks; No indication for cesarean section; Having a personal computer at home; Consent for participation; Residency at Isfahan. Exclusion criteria: Inability to attend prenatal education classes due to medical problems (such as Vaginal bleeding, Preeclampsia, Premature rupture of membranes, or any other indication for complete bed rest); The need for cesarean section due to medical reasons; Unwillingness to stay in the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
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
Isfahan University of Medical Sciences
Street address
Isfahan, Azadi Avenue, Hezarjerib Square
City
Isfahan
Postal code
8174673461
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.MUI.REC.1395.3.669

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O84
ICD-10 code description
Multiple delivery

Primary outcomes

1

Description
Delivery type
Timepoint
Two months after intervention
Method of measurement
Standard questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, women completed study questionnaires in the first prenatal education class and then, they were provided with a CD containing educational materials. They recompleted the questionnaires at the end of the last class.
Category
Other

2

Description
In the control group, women completed study questionnaires in the first and the last prenatal education classes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Community Center Shahid Nawab Safavi
Full name of responsible person
Expert's Preparation for Childbirth Classes
Street address
Ahmadabad Square
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Student Affairs Unit
Street address
Hezarjerib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
khadijeh Mohammadali Makhouli
Position
Master Student of Educational Health
Other areas of specialty/work
Street address
Alafchian Alley, Negarestan Avenue, Malekshahr
City
Isfahan
Postal code
8196753647
Phone
+98 31 3433 6812
Fax
Email
niloofar.makhouli@gmail.com kh.makhouli@hlth.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fereshteh Zamani Alavijeh
Position
Associate Professor
Other areas of specialty/work
Street address
Hezarjerib Avenue
City
Isfahan
Postal code
7346181746
Phone
+98 31 3668 0048
Fax
Email
fe.zamani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
khadijeh Mohammadali Makhouli
Position
Master Student of Educational Health
Other areas of specialty/work
Street address
Hezarjerib Avenue
City
Isfahan
Postal code
7346181746
Phone
+98 31 3668 0048
Fax
Email
niloofar.makhouli@gmail.com kh.makhouli@hlth.mui.ac.ir
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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