Protocol summary

Study aim
Comparison of the effect of national notification content with the suggestion of childbirth preparation classes on childbirth experience in pregnant women referring to Mashhad health centers.
Design
This study is a randomized controlled trial, with a control group, with parallel groups, one blind, on 100 pregnant women. The method of randomization is cluster type.
Settings and conduct
Mashhad health centers that are equipped with childbirth preparation classes and the necessary facilities for mothers to participate in the classes.
Participants/Inclusion and exclusion criteria
Inclusion: pregnant mothers with primiparous births, mother's age 18-35 years, gestational age at least 20 weeks, singleton pregnancy, having minimum literacy, predicting the possibility of having a natural birth, absence of currently known pregnancy complications, no history of medical illness or drug use, no history of infertility or use of assisted reproduction methods, no contraindications to exercise during pregnancy. Exclusion: having experience of participating in childbirth preparation classes elsewhere than this study, having pathological tokophobia from childbirth.
Intervention groups
Intervention group: pregnant women referring to health centers in Mashhad who participate in childbirth preparation classes according to the revised instructions. Control group: pregnant women referring to health centers in Mashhad who participate in childbirth preparation classes according to national guidelines.
Main outcome variables
Birth experience Including 4 dimensions (individual ability, sense of security and control, professional support and participation)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240709062375N1
Registration date: 2024-10-03, 1403/07/12
Registration timing: registered_while_recruiting

Last update: 2024-10-03, 1403/07/12
Update count: 0
Registration date
2024-10-03, 1403/07/12
Registrant information
Name
Mahla Shafei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5775 8084
Email address
shafei9811@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2025-08-11, 1404/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the impact of the national announced with proposed content of antenatal classes on the childbirth experience of pregnant women attending health centers in Mashhad
Public title
Comparison of the impact of the national announced with proposed content of antenatal classes on the childbirth experience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous pregnant mothers Mother's age 18-35 years Gestational age of at least 20 weeks singleton pregnancy Having at least reading and writing literacy Predicting the possibility of having a natural birth No current known pregnancy complications No history of medical illness or drug use Not having a history of infertility or using assisted reproductive methods Not having any contraindications for exercise during pregnancy (according to the published booklet of the country, such as placenta previa, high blood pressure, maternal fever, etc.)
Exclusion criteria:
having experience of participating in birth preparation classes in another place other than this research Having pathological tokophobia from childbirth
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The random method in this study is randomly classified in such a way that we randomly divide Mashhad's health-treatment centers into two groups in order to control the confounding factor (socio-economic). Then, I will select six centers from these centers and we will require these centers to be equipped with standard facilities and equipment to hold childbirth preparation classes for mothers to participate in the classes, so that they are at the same level in terms of facilities and equipment. take In the next step, we randomly classify these six centers into two groups again (by lottery) so that the referring mothers in each group are randomly assigned to intervention and control groups. In addition, this study has no concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
This research is a randomized controlled trial of a blind strain. In this study, the mothers participating in the class are not aware of what content is being taught to them and they have no knowledge of the old communicated content or the new suggested content.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University street, Mashhad, Khorasan Razavi,
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.028

Health conditions studied

1

Description of health condition studied
Comparison of the effect of nationally communicated content with the suggestion of childbirth preparation classes on childbirth experience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Birth experience
Timepoint
During the first 10 days after delivery
Method of measurement
Childbirth experience questionnaire (CEQ)

Secondary outcomes

1

Description
Satisfaction with childbirth
Timepoint
During the first 10 days after delivery
Method of measurement
McKee's childbirth satisfaction questionnaire

2

Description
Fear of childbirth
Timepoint
After the eighth session of childbirth preparation classes
Method of measurement
Vijma childbirth fear questionnaire, version A

Intervention groups

1

Description
Intervention group: Pregnant women referring to health centers in Mashhad who participate in childbirth preparation classes according to revised guidelines. Suggested content of the classes that will be taught in the intervention group. This content will be carried out in eight 90-minute sessions, similar to the notified content, and despite the fact that it will be in line with the goals of the Ministry of Health's maternal health, it will include changes that will either be added to the text or revised to the previous text. The suggested content is based on a review of published studies and research that the content of childbirth preparation classes as an intervention has led to favorable maternal and newborn outcomes.
Category
Other

2

Description
Control group: Pregnant women referring to health centers in Mashhad who participate in childbirth preparation classes according to national guidelines.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad health centers
Full name of responsible person
Mahla Shafei
Street address
Shahid Sotoudeh St, Khalilabad city, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
96751013751
Phone
+98 51 5775 8084
Email
shafei9811@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taskheti
Street address
university street, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
p.relations@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
Mahla Shafei
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Sotoudeh St, Khalilabad city, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
96751013751
Phone
+98 51 5775 8084
Email
shafei9811@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahla Shafei
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Sotoudeh St, Khalilabad city, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
96751013751
Phone
+98 51 5775 8084
Email
shafei9811@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahla Shafei
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Sotoudeh St, Khalilabad city, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
96751013751
Phone
+98 51 5775 8084
Email
shafei9811@gmail.com

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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