UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047484 |
|---|---|
| Receipt number | R000054121 |
| Scientific Title | Research on effect of a preconception care program by midwives for persons under the age of 25 such as university students |
| Date of disclosure of the study information | 2022/04/14 |
| Last modified on | 2022/10/17 16:45:59 |
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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
| Obstetrics 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
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
t-ishida@sophia.ac.jp
Sponsor or person
Institute
Japanese Midwives Association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054121
