UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective observational study about the influence of maternal nutrition and lifestyle care and thermo-controlling after birth and early mixed nutrition in infant on the health condition of mother, fetus and infant
Title of the study (Brief title)	Influence of nutrition and lifestyle care in mother and nutrition care and thermo-controlling in infant
Region	Japan

Condition
Condition	neonatal jaundice, newborns body weight loss, placental abruption, pregnancy-induced hypertension syndrome
Classification by specialty	Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the influence of the maternal and neonatal management in Kubota Maternity Clinic on the health condition in mother, fetus and infant.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of infant body weight, serum bilirubin values in infants, rate of neonatal jaundice, rate of phototherapy
Key secondary outcomes	The influence of maternal management in Kubota Maternity Clinic on the health condition of mother, fetus and infant

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	Not applicable
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Mother who received prenatal care at Kubota Maternity Clinic and infants who were born in Kubota Maternity Clinic from January first 1983 to June thirtieth 2017
Key exclusion criteria	Mother and infants whose data during pregnancy and after birth are deficient
Target sample size	30000

Research contact person
Name of lead principal investigator	Shiro Kubota
Organization	Kubota Maternity Clinic
Division name	Not applicable
Address	Hirao 2-12-18, Chuo-ku, Fukuoka, Fukuoka, Japan, 810-0014
TEL	+81-92-531-7615
Email	kubotahp@gmail.com

Public contact
Name of contact person	Tatsuya Yoshihara
Organization	Fukuoka Mirai Hospital
Division name	Clinical Research Center
Address	Kashii-teriha 3-5-1, Higashi-ku, Fukuoka, Fukuoka, Japan 817-0017
TEL	+81-92-662-3608
Homepage URL
Email	tatsuya@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute	Kubota Maternity Clinic
Institute
Department

Funding Source
Organization	Kubota Maternity Clinic
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 13 Day
Anticipated trial start date	2017 Year 07 Month 13 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	We collect the medical information below about mother who received prenatal care at Kubota Maternity Clinic and infants who were born in Kubota Maternity Clinic from January first 1983 to June thirtieth 2017. maternal age, height, weight, body weight change during pregnancy, pregnancy-induced hypertension syndrome, maternal complication, pregnancy history, gestational age, participation of maternity swimming, mode of delivery, duration of labor, gender of infant, Apgar score, birth weight, change of infant weight, bilirubin value, neonatal jaundice, phototherapy

Management information
Registered date	2017 Year 11 Month 17 Day
Last modified on	2017 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034233