UMIN-CTR Clinical Trial

Basic information
Public title	Research on effect of a preconception care program by midwives for persons under the age of 25 such as university students
Acronym	Effect of a preconception care program by midwives for persons under the age of 25
Scientific Title	Research on effect of a preconception care program by midwives for persons under the age of 25 such as university students
Scientific Title:Acronym	Effect of a preconception care program by midwives for persons under the age of 25
Region	Japan

Condition
Condition	healthy persons
Classification by specialty	Obsterics and gynecology Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of a preconception care program by midwives for college students and others under the age of 25.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Preconception Care Program will be assessed as follows. Each outcome will be assessed at immediately before, immediately after, and three months after the intervention. (1) The knowledge about preconception will be assessed using a self-reported questionnaire. The questionnaire was made by the research team based on the reports by WHO and CDC. It consists of 15 items. Each correct answer will be scored as one point and all answers will be added up to make total score (15 points).
Key secondary outcomes	(2)the awareness about preconception (3)the abilities and attitudes for life career(Kawasaki, 2010) Kawasaki, T. Scale construction on the abilities and attitudes for life career. The Japanese journal of career education, 29(1), 25-30, 2010.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	A preconception care program will be implemented for the subjects, practiced by midwives. Duration: 60 minutes 2. Lecture method: In principle, face-to-face; online depending on Covid-19 infection status. 3. Program content: (1) Healthy living, (2) Physical structure, (3) Pregnancy, (4) Safe and secure sex, (5) Progress of pregnancy and fetal growth, (6) Delivery, (7) Understanding the baby, (8) Social systems related to pregnancy, childbirth, and childcare.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	25 years-old >
Gender	Male and Female
Key inclusion criteria	College students and others between the age of 18 and 25
Key exclusion criteria	persons who do not understand Japanese
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Sakurai
Organization	SAKURAI JOSANIN(Birth Center of Midwifery)
Division name	None
Zip code	352-0004
Address	5-12-8 Owada, Niiza, Saitama
TEL	048-483-0926
Email	koshihikari@kde.biglobe.ne.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Ishida
Organization	Sophia University
Division name	Faculty of Human Sciences, Department of Nursing
Zip code	161-8550
Address	4-16-11 Shimoochiai, Shinjuku, Tokyo
TEL	03-3950-6071
Homepage URL
Email	t-ishida@sophia.ac.jp

Sponsor
Institute	Japanese Midwives Association
Institute
Department

Funding Source
Organization	Japanese Midwives Association
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Midwives Association
Address	2-12-2 Torigoe, Taito, Tokyo
Tel	03-3866-3054
Email	takahashi@midwife.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	309
Results	Scores on a review test measuring knowledge of future pregnancy, birth, and parenting were found to be significantly higher immediately after and three months after attending the program compared to before. There was also a significant increase in the things that participants felt they could work on for future pregnancy, birth, and parenting, reflecting an improvement in their awareness and attitudes. As these results, the program was effective.
Results date posted	2022 Year 10 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Undergraduate students from five universities who attended the program and were under the age of 25 years were included in the study. Following exclusion criteria were kept to a minimum to increase pragmatism and generalizability: students aged > 25 years or those unable to understand the program and surveys presented in Japanese.
Participant flow	Participants were recruited by providing them with an introduction to the program and a request for research participation posted on the website of the Japanese Midwives Association. Additional participants were recruited through snowball sampling; the researchers explained the program to college instructors they were acquainted with and asked them to implement the program and contribute to the research. Requests for research participation to students were made before the program was implemented using request forms distributed by the college instructors. Students who provided consent and participated in the program were surveyed using Google Forms. To evaluate the outcome of the program, questionnaire surveys were administered at T0, T1, and T2.
Adverse events	None.
Outcome measures	1.Knowledge related to future pregnancy, birth, and parenting: We created a PCC review test to evaluate understanding of the lecture content. The review test consisted of 15 questions; one correct answer from among five multiple choice options was to be selected. Each question was worth one point for a total of 15 points, with a higher score indicating greater knowledge related to future pregnancy, birth, and parenting. Measurements were taken at all three time periods. 2.Awareness and attitudes related to future pregnancy, birth, and parenting: Participants were asked to check items that they could improve on (from a list of six items) related to future pregnancy, birth, and parenting on the survey. Measurements were taken at all three time periods. 3.Program impressions: Participants were asked an open-ended question about their impressions of the program on the survey administered immediately after program completion and they could freely respond (T1).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 07 Month 09 Day
Date of IRB	2021 Year 07 Month 09 Day
Anticipated trial start date	2021 Year 08 Month 02 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 04 Month 30 Day
Date trial data considered complete	2022 Year 05 Month 31 Day
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2022 Year 04 Month 14 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054121