UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035934
Receipt No. R000035421
Scientific Title Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Date of disclosure of the study information 2019/04/01
Last modified on 2019/02/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Acronym Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Scientific Title Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Scientific Title:Acronym Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Region
Japan

Condition
Condition birth
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study was to assess the effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth, such as the type and place, among young women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate changes in hope for giving birth in the future and in interest concerning birthing method and birth place using VAS (visual analogue scale).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Participation is one day. We distribute pamphlets and give lectures on childbirth and health to intervention groups.
Interventions/Control_2 We distribute pamphlets to control group.
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
24 years-old >=
Gender Female
Key inclusion criteria Inclusion criteria are first grade nursing college university and general female college students aged 18 and over, 24 years old or younger.
Key exclusion criteria Exclusion criteria are men and those who have already taken maternity nursing studies, those who are experienced in pregnancy and childbirth.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nozomi Tamura
Organization Graduate School of Nara Medical University
Division name Graduate School of Nursing
Zip code
Address 840 Shijyo-cho, Kashihara-shi, Nara-ken
TEL 0744-22-3051
Email n.7323@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nozomi Tamura
Organization Graduate School of Nara Medical University
Division name Graduate School of Nursing
Zip code
Address 840 Shijyo-cho, Kashihara-shi, Nara-ken
TEL 0744-22-3051
Homepage URL
Email n.7323@naramed-u.ac.jp

Sponsor
Institute Graduate School of Nara Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 04 Month 01 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 19 Day
Last modified on
2019 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.