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
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
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
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
