Protocol summary
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Study aim
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This study aims to evaluate the effectiveness of an educational intervention program on fertility knowledge, childbearing intention and planned pregnancy rate among 1240 couples referring to premarital counselling centres.
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Design
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This study is a parallel randomised clinical trial with pre-test/post-test design.
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Settings and conduct
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This study will be conducted in five metropolitan cities of Iran with a diverse geographical distribution (Tehran, Mashhad, Ahvaz, Tabriz and Shiraz). Data will be collected by questionnaires at baseline and 3, 12 and 18 months after the intervention in each selected city. Participants will respond to a self-administered demographic characteristics questionnaire, the Cardiff Fertility Knowledge Scale (CFKS), the childbearing intention questionnaire and some questions about their pregnancy (planned/unplanned pregnancy). Given the nature of the intervention, it is not possible to blind participants to researchers involved in providing the intervention and data collection.
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Participants/Inclusion and exclusion criteria
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We plan to recruit new couples (men and women) referring for compulsory premarital counselling.
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Intervention groups
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The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing virtual (off-line) educational package at two time episodes with an interval of one month. The intervention includes text messages and short films. The control group will receive only typical premarital counselling.
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Main outcome variables
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The primary outcomes are fertility knowledge, childbearing intention and the first planned pregnancy rate (positive pregnancy test).
General information
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Reason for update
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Due to suspension of face-to-face premarital counseling during the COVID-19 pandemic in Iran, we have to change the protocol. In this regard, face-to-face training will not be provided for the intervention group. The intervention group will receive a fertility knowledge package containing only virtual (off-line) educational package at two time episodes with an interval of one month. The intervention includes text messages and short films.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201005048925N1
Registration date:
2020-10-12, 1399/07/21
Registration timing:
prospective
Last update:
2022-01-12, 1400/10/22
Update count:
1
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Registration date
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2020-10-12, 1399/07/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-21, 1399/09/01
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Expected recruitment end date
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2022-11-22, 1401/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of an educational intervention on fertility knowledge, childbearing intention and planned pregnancy among new couples referring to premarital counselling centers: a randomized clinical trial
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Public title
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Effectiveness of an educational intervention on fertility knowledge, childbearing intention and planned pregnancy among new couples
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Childless couples are about to live together in their new home (under one roof) in the near future
having an Iranian nationality
Minimum basic literacy
Aging from 18 to 35 years, men aging 18-45
Lacking prior marriage history
Exclusion criteria:
Medical students or staff
Having any known chronic diseases
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Age
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From 18 years old to 35 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
1240
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples will be selected through stratified sampling and random samples are then selected from each stratum. The strata consist of 5 cities and separate randomization lists will be prepared for each city using a block randomization.
Then we will use central randomization that is stratified to the cities.
The couples will randomly be assigned into 2 groups in each city by a computer-generated random sequence.
For randomization, the permuted block randomization will be used (block size=4). According to the sample size of 440 identified, 110 blocks will be produced using the online site (www.sealedenvelope. com) for Tehran.
According to the sample size of 200 identified, 50 blocks will be produced using the online site (www.sealedenvelope. com) for other cities.
Allocation will be concealed by using sequentially numbered opaque sealed envelopes that contain group assignments determined by computer-generated random sequences.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Given the nature of the intervention, it is not possible to blind participants to researchers involved in providing the intervention and data collection. However, allocation to intervention or control groups will be blinded for researchers in the data set available during data analysis.
To avoid the potential contamination between two groups, we will provide the educational intervention after the typical premarital counselling.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-08-09, 1399/05/19
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Ethics committee reference number
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IR.NIMAD.REC.1399.123
Health conditions studied
1
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Description of health condition studied
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Fertility knowledge
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Childbearing intention
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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Planned pregnancy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Fertility knowledge
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Timepoint
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Data will be collected by at baseline and 3, 12 and 18 months after the intervention.
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Method of measurement
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Cardiff Fertility Knowledge Scale (CFKS)
2
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Description
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Childbearing intention
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Timepoint
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Data will be collected by at baseline and 3, 12 and 18 months after the intervention.
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Method of measurement
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The childbearing intention questionnaire
3
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Description
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Planned pregnancy (positive pregnancy test)
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Timepoint
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Data will be collected by at baseline and 3, 12 and 18 months after the intervention.
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Method of measurement
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Demographic and fertility characteristics questionnaire
Secondary outcomes
1
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Description
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Contraception method
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Timepoint
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Baseline, 3, 12 and 18 month after intervention
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Method of measurement
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Demographic and reproductive characteristic questionnaire
2
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Description
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Miscarriage
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Timepoint
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Baseline, 3, 12 and 18 month after intervention
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Method of measurement
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Demographic and reproductive characteristic questionnaire
3
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Description
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Unplanned pregnancy
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Timepoint
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Baseline, 3, 12 and 18 month after intervention
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Method of measurement
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Demographic and reproductive characteristic questionnaire
Intervention groups
1
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Description
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Intervention group: The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing virtual (off-line) educational package at two time episodes with an interval of one month. The intervention includes text messages and short films. The content of educational or counselling program will be based on the most updated literature on fertility knowledge. The fertility knowledge package will consist of information on fertility rates, infertility rates, risks of delay in childbearing, safe waiting period for parenting, Impact of age on female fertility, limited fertility period for women, fertility window and how to optimize fertility, impact of weight and lifestyle on fertility, definition of infertility, infertility risk factors, impact of STD on fertility, the need for earlier evaluation and treatment of infertility, success rate and financial costs of infertility treatments, assisted conception and fertility preservation.
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Category
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Other
2
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Description
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Control group: The control group will receive only typical premarital counselling in public health centers.
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Category
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Other
1
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Sponsor
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Grant name
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Young Researcher Grant 2020
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Grant code / Reference number
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۹۸۸۵۲۳
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Institue for Medical Research Development (NIMAD)
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Study protocol
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When the data will become available and for how long
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One year after starting the study
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To whom data/document is available
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The study protocol will be available to everyone in the form of a paper after its publication.
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Under which criteria data/document could be used
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The study protocol can be used to design the similar studies.
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From where data/document is obtainable
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The protocol will be available through the journal website.
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What processes are involved for a request to access data/document
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The study protocol will be available immediately after the article is published.
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Comments
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protocol link:
https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-10029-4