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investigating the effect of group counseling based on motivational interview on awareness, attitude and choice of delivery in women with previous caesarean section

Protocol summary

Study aim
Determining the effect of motivational interview based on group counseling on the awareness, attitude and intention the choice of natural delivery in women with previous cesarean section history in Mashhad health centers in 1397
Design
Clinical trials have a control group and randomization, without blindness
Settings and conduct
At first, five centers of health centers in Mashhad, Center No 3 were randomly selected. Then, based on the population coverage and having the right place for consultation, four centers were selected. Random assignment of groups was done using enclosed envelopes. Finally, the intervention group is selected on the days of the single ,and the control group is selected on the day of the couple.
Participants/Inclusion and exclusion criteria
inclusion criteria contains: desire to participate in a previous cesarean section study, gestational age of 30-28 weeks, single pregnancy, live embryo and cephalic presentation, normal amniotic fluid and placement status based on ultrasonography of pregnancy, more than 6 months with previous delivery exclusion criteria includes: indication of cesarean section, medical or obstetric disease, non-transverse cesarean section
Intervention groups
The intervention consists of three group counseling sessions for 90-60 minutes based on the motivational interview structure.The control group receives the same advice as the midwife of the center
Main outcome variables
Knowledge score for normal delivery after cesarean delivery   Attitude score toward normal delivery after cesarean delivery And the frequency of the intention to choose a natural birth after cesarean section

General information

Reason for update
Acronym
VBAC
IRCT registration information
IRCT registration number: IRCT20180714040463N1
Registration date: 2018-10-11, 1397/07/19
Registration timing: registered_while_recruiting

Last update: 2018-10-11, 1397/07/19
Update count: 0
Registration date
2018-10-11, 1397/07/19
Registrant information
Name
Zahra Hoseini haji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 5281
Email address
hoseinihz951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating the effect of group counseling based on motivational interview on awareness, attitude and choice of delivery in women with previous caesarean section
Public title
investigating the effect of group counseling based on motivational interview on awareness, attitude and choice of delivery in women with previous caesarean section
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Mashhad. Aged 18-35 years old A willingness to collaborate on research At least have the ability to read and write Single-pregnancy. A live embryo and a cephalic display. Amniotic fluid and placental placement are normal based on pregnancy ultrasonography. The gestational age based on the LMP or the first trimester ultrasound is of 28-30 weeks. History of once prior cesarean section The interval between pregnancy and previous delivery is greater than 6 months.
Exclusion criteria:
indication of cesarean section. Have a history of infertility. Embryo abnormalities are contraindicated in normal delivery. Have a medical or obstetric illness. Non-transverse cesarean section. Have a mental illness.
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: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. Indirect packets were used. .
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
Mashhad University of Medical Sciences and Health Services
Street address
Khorasan Razavi - Mashhad-Ave. University- Facing Khayyayan University 18- Mashhad University of Medical Sciences- Vice-President of Research and Technology University
City
Mashhad
Province
Razavi Khorasan
Postal code
38430249-051
Approval date
2018-07-07, 1397/04/16
Ethics committee reference number
IR.MUMS.REC.1397.097

Health conditions studied

1

Description of health condition studied
vaginal birth after cesarean delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knowledge towards normal delivery after cesarean
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
The score obtained from the researcher-made questionnaire was the knowledge toward natural delivery after cesarean section.

2

Description
attitude towards normal delivery after cesarean section
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
The score obtained from the researcher-made questionnaire was the attitudetoward natural delivery after cesarean section.

3

Description
Frequency of intention to choose natural delivery after cesarean section
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
The score obtained from the researcher-made questionnaire was the intention of choice of natural delivery after cesarean section.

Secondary outcomes

empty

Intervention groups

1

Description
intervention group:The 'intervention group" receives three groups of motivational interviewing counseling sessions for 60-90 minutes and once every two weeks, based on a structure developed by the researcher and approved by a professor of psychology
Category
Behavior

2

Description
Control group: The "control group" receives routine counseling about vaginal birth after cesarean by midwives at health centers.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 3 of Mashhad
Full name of responsible person
Baratali Arab Nejad
Street address
Khayyam Blvd - Ershad Blvd. 8 - Message Street - Opposite Message 6
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3763 4007
Email
presidentoffice@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Darabi mahboob
Street address
Khorasan Razavi - Mashhad - University Street - Gharishi Building Presidential Building of Razavi Khorasan University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 3007
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hosseini Haji
Position
Student Of Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 36, 9th Ave., Bahonar Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9148975645
Phone
+98 0518705281
Email
Hoseinihz951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboobe Firoozi
Position
Faculty of Medicine, Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faramarz Abbasi Boulevard, Baharan, Fajr 14, plain 9
City
Mashhad
Province
Razavi Khorasan
Postal code
0939590654
Phone
+98 0517634530
Email
Firoozim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboobe Firoozi
Position
Faculty of Medicine, Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faramarz Abbasi Boulevard, Baharan, Fajr 14, plain 9
City
Mashhad
Province
Razavi Khorasan
Postal code
0939590654
Phone
+98 0517634530
Email
Firoozim@mums.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
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