UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	survey of changes in food preference by pregnancy
Title of the study (Brief title)	survey of changes in food preference by pregnancy
Region	Japan

Condition
Condition	pregnancy
Classification by specialty	Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to clarify whether food preference of the woman changes by pregnancy.
Basic objectives2	Others
Basic objectives -Others	Factors concerned with change of food preference.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcome is to investigate the ratio of woman who changes food preference by pregnancy.
Key secondary outcomes	Factors concerned with change of food preference. Age, the first pregnancy or not, partner's food preference and so on.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	45 years-old >=
Gender	Female
Key inclusion criteria	A woman after the delivery
Key exclusion criteria	no exclusion criteria
Target sample size	200

Research contact person
Name of lead principal investigator	Masayuki Miwa
Organization	National Hospital Organization Saitama National Hospital
Division name	department of Pediatrics
Address	Suwa 2-1, Wako, Saitama pref., Japan
TEL	048-462-1101
Email	m38miwa@z2.keio.jp

Public contact
Name of contact person	Masayuki Miwa
Organization	National Hospital Organization Saitama National Hospital
Division name	department of Pediatrics
Address	Suwa 2-1, Wako, Saitama pref., Japan
TEL	048-462-1101
Homepage URL
Email	m38miwa@z2.keio.jp

Sponsor
Institute	Department of Pediatrics, Saitama National Hospital
Institute
Department

Funding Source
Organization	Department of Pediatrics, Saitama National Hospital
Organization
Division
Category of Funding Organization	Self funding
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	国立病院機構埼玉病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 09 Day
Anticipated trial start date	2015 Year 10 Month 26 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 07 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is a retrospective cohort study to investigate whether a change of food preferencw occurred to the woman who became pregnant. We perform a questionnaire to puerperae, who gave birth in Saitama National Hospitl, at the time of one month age medical examination of baby.

Management information
Registered date	2015 Year 10 Month 25 Day
Last modified on	2018 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022539