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
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.
Design
This study is a parallel randomised clinical trial with pre-test/post-test design.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
We plan to recruit new couples (men and women) referring for compulsory premarital counselling.
Intervention groups
The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing verbal and virtual educational package at five time episodes (one verbal session and four virtual sessions). We will implement the educational programs during 4 weeks. The intervention includes a 30-minute lecture, documentary videos, text messages and short films. The control group will receive only typical premarital counselling.
Main outcome variables
The primary outcomes are fertility knowledge, childbearing intention and the first planned pregnancy rate (positive pregnancy test).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048925N1
Registration date:2020-10-12, 1399/07/21
Registration timing:prospective
Last update:2020-10-12, 1399/07/21
Update count:1
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Fahimeh Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 1613
Email address
ranjbar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effectiveness of an educational intervention on fertility knowledge, childbearing intention and planned pregnancy among new couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
1240
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Institute for Medical Research Development (NIMAD)
Street address
No.21, Besat Ave., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.NIMAD.REC.1399.123
Health conditions studied
1
Description of health condition studied
Fertility knowledge
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Childbearing intention
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Planned pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fertility knowledge
Timepoint
Data will be collected by at baseline and 3, 12 and 18 months after the intervention.
Method of measurement
Cardiff Fertility Knowledge Scale (CFKS)
2
Description
Childbearing intention
Timepoint
Data will be collected by at baseline and 3, 12 and 18 months after the intervention.
Method of measurement
The childbearing intention questionnaire
3
Description
Planned pregnancy (positive pregnancy test)
Timepoint
Data will be collected by at baseline and 3, 12 and 18 months after the intervention.
Method of measurement
Demographic and fertility characteristics questionnaire
Secondary outcomes
1
Description
Contraception method
Timepoint
Baseline, 3, 12 and 18 month after intervention
Method of measurement
Demographic and reproductive characteristic questionnaire
2
Description
Miscarriage
Timepoint
Baseline, 3, 12 and 18 month after intervention
Method of measurement
Demographic and reproductive characteristic questionnaire
3
Description
Unplanned pregnancy
Timepoint
Baseline, 3, 12 and 18 month after intervention
Method of measurement
Demographic and reproductive characteristic questionnaire
Intervention groups
1
Description
Intervention group: The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing verbal and virtual educational package at five time episodes (one verbal session and four virtual sessions). We will implement the educational programs during 4 weeks. The intervention includes a 30-minute lecture, documentary videos, 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.
Category
Other
2
Description
Control group: The control group will receive only typical premarital counselling in public health centers.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Haft Tir Health Center
Full name of responsible person
Ziba Najafipour
Street address
Monjem Ave, Naser Cross road
City
Tabriz
Province
West Azarbaijan
Postal code
00000000000
Phone
+98 41 3283 0361
Email
name@domian.com
2
Recruitment center
Name of recruitment center
Asad Abadi Health Center
Full name of responsible person
Nahid Azimzadeh
Street address
Bahar Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
000000000000
Phone
+98 41 3282 1068
Email
name@domian.com
3
Recruitment center
Name of recruitment center
Taghinia Health Center
Full name of responsible person
Mahrokh Alaee
Street address
Shahparvari Ave., Shamshiri Sq.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6669 6373
Email
name@domian.com
4
Recruitment center
Name of recruitment center
Farmanfarmayan Ave,
Full name of responsible person
Roghieh Varmazyari
Street address
Between Golshan and Bastan, Azarbaijan Ave.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6692 8488
Email
name@domian.com
5
Recruitment center
Name of recruitment center
Ershad Health center
Full name of responsible person
Nematollah Mohammadinia
Street address
Shariati Ave., Hadiye Alley.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2225 7699
Email
name@domian.com
6
Recruitment center
Name of recruitment center
Baharneko
Full name of responsible person
Abbas Soltani
Street address
No 10., Mollasadra Ave.
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۴۵۵۵۱
Phone
+98 71 3234 2110
Email
name@domian.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institue for Medical Research Development (NIMAD)
Full name of responsible person
Fahimeh Ranjbar
Street address
No. 21, Besat Ave., West Fatemi Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Fax
Email
NIMAD@RESEARCH.AC.IR
Grant name
Young Researcher Grant 2020
Grant code / Reference number
۹۸۸۵۲۳
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institue for Medical Research Development (NIMAD)
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
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Ranjbar
Position
Asistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Reproductive Health
Street address
Vanak, Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
19395-4798
Phone
+98 21 8867 1613
Fax
Email
ranjbar.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Ranjbar
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi St., Valiasr Ave.,
City
Tehran
Province
Tehran
Postal code
19395-4798
Phone
0098218671613
Email
ranjbar.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Ranjbar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vank, Rashid yasemi Ave
City
Tehran
Province
Tehran
Postal code
19395-4798
Phone
+98 21 8867 1613
Email
ranjbar.f@iums.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
Yes - There is 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
No - There is not 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
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
Study protocol
When the data will become available and for how long
One year after starting the study
To whom data/document is available
The study protocol will be available to everyone in the form of a paper after its publication.
Under which criteria data/document could be used
The study protocol can be used to design the similar studies.
From where data/document is obtainable
The protocol will be available through the journal website.
What processes are involved for a request to access data/document
The study protocol will be available immediately after the article is published.