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 UMIN000030011
Receipt No. R000034233
Scientific Title 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
Date of disclosure of the study information 2017/11/17
Last modified on 2017/11/17

* 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 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
Acronym Influence of nutrition and lifestyle care in mother and nutrition care and thermo-controlling in infant
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Shiro Kubota
Organization Kubota Maternity Clinic
Division name Not applicable
Zip code
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
1st name
Middle name
Last name Tatsuya Yoshihara
Organization Fukuoka Mirai Hospital
Division name Clinical Research Center
Zip code
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)

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
2017 Year 11 Month 17 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
2017 Year 07 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.