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Investigating the effect of the educational intervention on the propensity to have children in married women of reproductive age in Neyshabur city in 2023

Protocol summary

Study aim
The effect of educational intervention on the Childbearing Intention in married women
Design
using a computer-generated random number sequence (www.randomizer.org) with a 1:1 allocation ratio and a block size of 4. Allocation concealment was ensured by using sequentially numbered, opaque, sealed envelopes prepared.96 persson in each group
Settings and conduct
This research conducted in selected comprehensive health centers of Neyshabur , and sampling will be done using a quota method. Participants: all women of reproductive age between 15–49 years , visit comprehensive health centers. After randomly assigning individuals to control and intervention groups, and following the completion of a written informed consent form, a demographic information form and a questionnaire on the tendency toward childbearing will be administered to both groups of women. Then, among women who receive a lower score on the tendency toward childbearing, they will be invited to participate in the study if they wish,
Participants/Inclusion and exclusion criteria
Written informed consent, age 15 to 49 years, Iranian nationality, married, fewer than 4 children, no history of medical conditions, no use of psychoactive drugs, cigarettes, or alcohol, no depression, no disorders that would make pregnancy high-risk, health record.
Intervention groups
Participants in the intervention group received a structured educational program consisting of four 60-minute sessions held over two weeks
Main outcome variables
Tendency toward childbearing / Fertility desire · Interval between marriage and first childbirth · Duration of marriage · Sex of children (or Gender of children) · Type of delivery (e.g., vaginal / C-section) · Economic status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260510069337N1
Registration date: 2026-05-14, 1405/02/24
Registration timing: prospective

Last update: 2026-05-14, 1405/02/24
Update count: 0
Registration date
2026-05-14, 1405/02/24
Registrant information
Name
Mahboobe Gholami
Name of organization / entity
Neyshabur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3733 2137
Email address
gholamim1@nums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-10, 1405/03/20
Expected recruitment end date
2027-06-10, 1406/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the educational intervention on the propensity to have children in married women of reproductive age in Neyshabur city in 2023
Public title
effect of the educational intervention on the propensity to have children
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent age 15 to 49 years, Iranian nationality married, fewer than 4 children no history of medical conditions no use of psychoactive drugs, cigarettes, or alcohol no depression no disorders that would make pregnancy high-risk having a health record.
Exclusion criteria:
unwillingness to continue participating in the research absence from more than one session of the fertility education sessions.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 196
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible and willing participants were randomly assigned to either the intervention or control group using a computer-generated random number sequence (www.randomizer.org) with a 1:1 allocation ratio and a block size of 4. Allocation concealment was ensured by using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher who was not involved in participant recruitment or outcome assessment. The envelopes were opened by a research assistant only after the participant had completed the baseline questionnaire and just before the intervention began
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Neyshabur University of Medical Sciences
Street address
ImamKhomeini27 Avenue
City
Neyshabur
Province
Razavi Khorasan
Postal code
9313867539
Approval date
2026-05-12, 1405/02/22
Ethics committee reference number
IR.NUMS.REC.1403.034

Health conditions studied

1

Description of health condition studied
Fertility Desire
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fertility Desire
Timepoint
at baseline, immediately post-intervention, and at three-month follow-up
Method of measurement
Fertility Tendency Questionnaire Enayat

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational content, validated by a panel of ten national experts in population and fertility studies, was based on the Health Belief Model constructs (perceived benefits, perceived barriers, self-efficacy, cues to action). Topics included: disadvantages of single-child families, advantages of having multiple children, benefits of pregnancy and breastfeeding for maternal health, positive impacts of childbearing on family cohesion, and correcting common misconceptions about pregnancy and childbirth risks
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Neyshabur university of Medical Sciences
Full name of responsible person
Mahboobe Gholami
Street address
Imam Khomeini27 Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
9313867539
Phone
+98 51 4262 7501
Email
gholamim26279@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Dr. Ali Gholami
Street address
Neyshabur University of Medical Sciences, Moallem Sq., Neyshabur, Khorasan Razavi, I.R. Iran.
City
Neyshabur
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7501
Email
gholamim26279@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Mahboobe Gholami
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Moallem Sq., Neyshabuق
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4262 7505
Email
gholamim26279@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mahboobe Gholami
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Moallem Sq., Neyshabuق
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4262 7505
Email
gholamim26279@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mahboobe Gholami
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Moallem Sq., Neyshabuق
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4262 7505
Email
gholamim26279@gmail.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
"All data can be shared after de-identifying individuals."
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no other conditions
From where data/document is obtainable
Gholamim26279@gmail.com Mahboobe Gholami
What processes are involved for a request to access data/document
The applicant should send a request email along with their details; the research deputy should give permission, and the data should be emailed to them."
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