UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030011
Receipt number 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 13:22:38

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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

Obstetrics 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 or person

Institute

Kubota Maternity Clinic

Institute

Department

Personal name



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

Value
https://center6.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