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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034730
Receipt No. R000038455
Official scientific title of the study Effect of prenatal education on pregnant women on prevention of infants allergic diseases:assessor-blind, randomized, controlled trial
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/01

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Basic information
Official scientific title of the study Effect of prenatal education on pregnant women on prevention of infants allergic diseases:assessor-blind, randomized, controlled trial
Title of the study (Brief title) Effect of prenatal education on pregnant women on prevention of infants allergic diseases:assessor-blind, randomized, controlled trial


Region
Japan

Condition
Condition atopic dermatitis, food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this trial is to evaluate whether prenatal education interventions, including the latest public research results on allergic diseases, prevent infant allergies onset.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavioral characteristics in mother's life and child rearing at 4-months old

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Prenatal education by pediatric allergist specialist and pediatric allergic educator
twice in total, once in the early and late stages of pregnancy
Interventions/Control_2 Distribution of leaflet summarizing educational contents to be done for intervention group in the first and second term of pregnancy
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria All of the following A) to C) are satisfied

A) Pregnant women planning to give birth at the Chiba Aiyukai Kinen Hospital
B) Pregnant woman planning to participate in the mother's class held at Chiba Aiyukai Kinen Hospital
C) A pregnant woman who understands the research subject and gained consent in writing
Key exclusion criteria Exclude from the research if any of the following applies

A) Do not give birth at Chiba Aiyukai Kinen Hospital
B) never participate in mother's class
C) Births less than 36 weeks or low birth weight babies weighing less than 2000 g
D) three or more multifetal
E) If you have severe congenital malformations
F) abnormal delivery: fetal urgency aspiration, neonatal asphyxia
G) Other pregnant women / children who the physician deemed inappropriate
Target sample size 120

Research contact person
Name of lead principal investigator Yoko Nedu
Organization Chiba Aiyukai Kinen Hospital
Division name Pediatrics
Address 1-1, Hiregasaki, Nagareyama-Shi Chiba 270-0161 Japan
TEL 04-7159-1611
Email yknezu@gmail.com

Public contact
Name of contact person Yoko Nedu
Organization Chiba Aiyukai Kinen Hospital
Division name Pediatrics
Address 1-1, Hiregasaki, Nagareyama-Shi Chiba 270-0161 Japan
TEL 04-7159-1611
Homepage URL http://chibaaiyu-kai.com/
Email yknezu@gmail.com

Sponsor
Institute Chiba Aiyuka Kinen Hospital
Institute
Department

Funding Source
Organization Chiba Aiyuka Kinen Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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