Protocol summary
-
Study aim
-
Determining the effect of education based on the theory of planned behavior on the intention and behavior of natural delivery after previous cesarean section in pregnant women
-
Design
-
The study have a control and a intervention parallel randomized groups, on 70 people. By selecting the numbers, the eve number to the control and the odd number to the intervention.
-
Settings and conduct
-
study is performed on pregnant mothers with a history of cesarean section with two groups of control and intervention. The control group will receive routine care. After completing the study, a training session on educational content will be provided to them with an educational pamphlet. For the intervention group, training will be in 4 sessions. classes will be held in groups of 7 to 10 people. The education of all groups will be same and adjusted based on the pre-test analysis. content based on the theory of planned behavior.The time of training will be 90 min. It will include topics related to the benefit and disadvantages of each of delivery methods, pictures and videos related to the delivery process for training. In the last session, the post-test questionnaire was completed in both groups, and also a month later, it will be completed again. To measure the change in behavior, telephone follow-up after delivery will be done in both groups.
-
Participants/Inclusion and exclusion criteria
-
History of cesarean section; age 18 to 35 years old; single pregnancy; gestational age 26- 34 weeks. No medical indication for cesarean section; no underlying mental illness; no vertical incision on the abdomen.
Exclusion criteria: absence from more than one training session.
-
Intervention groups
-
Research community in two groups: the intervention who received theory-based training and the control group who received routine training.
-
Main outcome variables
-
Intention of Vaginal Delivery after cesarean ( VBAC); doing VBAC
General information
-
Reason for update
-
Although the study was not related to the disease, this field was incorrectly completed.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200519047509N1
Registration date:
2020-11-13, 1399/08/23
Registration timing:
registered_while_recruiting
Last update:
2020-12-07, 1399/09/17
Update count:
1
-
Registration date
-
2020-11-13, 1399/08/23
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-07-22, 1399/05/01
-
Expected recruitment end date
-
2020-11-21, 1399/09/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of educational intervention based on the Theory of Planned Behavior on the intention and Behavior of vaginal birth after Previous cesarean among pregnant women referred to health centers in Ardabil.
-
Public title
-
The effect of educational intervention based on the Theory of Planned Behavior on the intention and Behavior of vaginal birth after Previous cesarean among pregnant women.
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Reading and writing Persian literacy
Age range 18 to 35 years
Single pregnancy
Pregnancy 26 to 34 weeks
Lack of medical indications for cesarean section
Lack of mental illness
No vertical incisions in the abdomen
If the cause of previous cesarean section is not present in this pregnancy
Having consent to participate in research
Exclusion criteria:
Any disease added to the pregnancy that makes cesarean section unavoidable for the mother
Suffering from any complications during pregnancy such as high blood pressure during pregnancy, decolman, fetal death, premature rupture of membrane, preterm delivery
Failure to attend more than one training session
-
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:
70
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
In this way, the numbers 1 to 70 are written on separate papers and poured into a bowl. And participants selects one of these papers from inside the bowl. Even numbers will be entered into the control group and odd numbers will be
assigned to the intervention group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-05-13, 1399/02/24
-
Ethics committee reference number
-
IR.UMSU.REC.1399.037
Health conditions studied
1
-
Description of health condition studied
-
Vaginal delivery after a history of cesarean section
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Intention to have a normal delivery
-
Timepoint
-
At the beginning of the study (before the intervention), the last session of the intervention and one month after the intervention
-
Method of measurement
-
Researcher-made validity and reliability questionnaire
2
-
Description
-
Behavior of normal delivery after a history of cesarean section
-
Timepoint
-
At the beginning of the study (before the intervention), the last session of the intervention and one month after the intervention
-
Method of measurement
-
Researcher-made validity and reliability questionnaire
Intervention groups
1
-
Description
-
Intervention group: for the intervention group, face-to-face training will be arranged in 4 training sessions, which are held once a week. Training classes will be held in groups of 7 to 10 people so that group discussions are possible. The educational content of all groups will be the same and will be adjusted based on the needs assessment of the analysis of pre-test results. The educational content will be based on the structures of the theory of planned behavior. The time of face-to-face training will be 90 minutes. It will include topics related to the advantages and disadvantages of each of the cesarean delivery methods and VBAC, etc. Also, educational pictures and videos related to the delivery process will be used for training. In the last session of the educational intervention, the post-test questionnaire was completed in both intervention and control groups, and also a month later, it will be completed again in both groups. To measure the change in behavior, telephone follow-up of the type of delivery after delivery will be done in both groups.
-
Category
-
Other
2
-
Description
-
Control group: this group receives prenatal routine trainings. In addition, in order to observe research ethics, at the end of the intervention, a training session is held to observe research ethics and a pamphlet containing educational content is delivered to this group. Corona hygiene will be observed.
-
Category
-
Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Urmia 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is 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
-
Yes - There is 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
-
Title and more details about the data/document
-
After identifying the completed questionnaires before and after the intervention, the target group will be provided to the ethics committee and will be kept in a safe place for a limited time....
-
When the data will become available and for how long
-
5 years
-
To whom data/document is available
-
Research team and esteemed members of the University Ethics Committee
-
Under which criteria data/document could be used
-
Only for members of the research team and inspectors of the ethics committee for verification
-
From where data/document is obtainable
-
Tamara Dargahi
-
What processes are involved for a request to access data/document
-
Contact and coordinate with all members of the research team
-
Comments
-