Effectiveness of a standardized program of contraceptive education and counseling provided by midwives: A study protocol for a randomized controlled trial

Introduction Contraceptive education and counseling have been shown to be effective in other countries, but there are no standardized programs currently in use. The purpose of this study is to develop a standardized program of contraceptive education and counseling, and to provide a detailed protocol for testing the effectiveness of midwives' implementation of this program. Methods The study will be a prospective randomized controlled trial for women aged 18–30 years who wish to use or consider contraception. As a preparatory step, a standard contraceptive education video will be produced in the first phase and an educational program for midwives responsible for counseling will be implemented in the second phase. In the third phase of the intervention, subjects will be stratified into healthcare-related and non-healthcare-related groups, and then randomize into two groups: an intervention group that will receive video viewing and midwifery counseling; and a control group that will receive video viewing only. The primary outcome is the percentage of participants who indicated self-determined use of contraception, with questionnaires administered before, immediately after, and 3 months after the program. Secondary outcomes include knowledge test scores, self-affirmation scale scores on contraception, frequency of opportunities to talk about contraception, and frequency of contraceptive (or non-contraceptive) sexual activity. Data will be analyzed using χ2 or t-tests for descriptive statistics and pre- and post-intervention comparisons, and one-way analysis of variance will be used to assess changes over time from baseline to 3 months after the program. Discussion This study will be the first in Japan to examine the effects of individualized contraceptive counseling provided by midwives as preconception care for the younger generation. Therefore, it is expected to contribute to a participants' decision-making and satisfaction with counseling, and may enable more appropriate self-determination, taking into consideration participants' relationships with their partners and other relevant factors.