UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031809 |
|---|---|
| Receipt number | R000036319 |
| Scientific Title | Predictors of successful pregnancy outcome and fetal prognosis: an observational retrospective-prospectivestudy |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2024/09/06 14:45:46 |
* 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
Predictors of successful pregnancy outcome and fetal prognosis: an observational retrospective-prospectivestudy
Acronym
Predictors of successful pregnancy outcome and fetal prognosis: an observational retrospective-prospectivestudy
Scientific Title
Predictors of successful pregnancy outcome and fetal prognosis: an observational retrospective-prospectivestudy
Scientific Title:Acronym
Predictors of successful pregnancy outcome and fetal prognosis: an observational retrospective-prospectivestudy
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between successful pregnancy and birth outcome, and social, lifestyle and metabolic / histological factors of pregnancy women who living in Japan.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between successful pregnancy and birth outcome, and social, lifestyle and metabolic / histological factors of pregnancy women who living in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Low Birth Weight (LBW)
Key secondary outcomes
Small for gestational age (SGA),
Gestational body weight gain (GWG),
Hypertensive disorder of pregnancy (HDP)
Gestational diabetes mellitus (GDM),
Preterm birth (PTB),
Stillbirth,
Emergency CS,
NICU use
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
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnancy women who delivery in our institution during study period
Key exclusion criteria
Person who disagree against being participant
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Abiko |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
6128555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
abiko.kaoru.hf@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Ikuyo |
| Middle name | |
| Last name | Hayashi |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute for Endocrine and Metabolic Disease
Zip code
6128555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
suganuma.akiko.wh@mail.hosp.go.jp
Sponsor or person
Institute
Division of Preventive Medicine, Clinical Research Institute for Endocrine and Metabolic Disease, National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan,
Tel
075-641-9161
naoki.sakane.zn@mail.hosp.go.jp
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
| 2018 | Year | 03 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants:
Pregnant women who delivery had occurred between 01 January 1998 to 31 December 2019
Management information
Registered date
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036319
