A multicenter randomized controlled trial protocol to evaluate the effectiveness of an educational intervention on ferti
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A multicenter randomized controlled trial protocol to evaluate the effectiveness of an educational intervention on fertility knowledge, intention and behavior among Iranian new couples Maryam Gharacheh1, Farideh Khalajabadi Farahani2, Mojgan Mirghafourvand3, Leila Janani4 and Fahimeh Ranjbar1*
Abstract Background: Recent evidence shows that men and women have inadequate fertility knowledge which may negatively affect their childbearing decisions in future. Given the fact that decision making for fertility needs accurate information, targeted educational interventions especially through media are needed to improve knowledge regarding the best age of fertility, factors affecting fertility potential and fertility options available for sub-fertile couples. Aim of the study is to evaluate whether a fertility educational program can be effective in increasing fertility knowledge, childbearing intention and the planned pregnancy rate among couples referring to premarital counselling centers. Methods: This study is a parallel randomised clinical trial with pre-test/post-test design. We will recruit 1240 marrying couples referring for compulsory premarital counselling in public health centers through stratified sampling in five metropolitan cities of Iran. 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) within 4 weeks. The primary outcomes are fertility knowledge, childbearing intention and the first planned pregnancy rate (positive pregnancy test) and the secondary outcomes include contraception method use, miscarriage and unplanned pregnancy. Participants will respond to a self-administered demographic/reproductive characteristics questionnaire, the Cardiff Fertility Knowledge Scale (CFKS) and the childbearing intention questionnaire. Data will be collected through online questionnaires at baseline and 3, 12 and 18 months after the intervention. Data will be analyzed using Chi-square or Fisher-exact test for categorical variables, Independent sample t-test for normally distributed quantitative variables and Mann–Whitney U test for non-normally distributed quantitative variables. To compare the outcomes between the two groups over the time, repeated measures ANOVA will be (Continued on next page)
* Correspondence: [email protected] 1 Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
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