UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049759 |
|---|---|
| Receipt number | R000056675 |
| Scientific Title | Development of nutritional guidance program for pregnant women at risk of giving birth to low birth weight infants. |
| Date of disclosure of the study information | 2022/12/14 |
| Last modified on | 2023/07/11 20:11:12 |
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Basic information
Public title
Development of nutritional guidance program for pregnant women at risk of giving birth to low birth weight infants.
Acronym
Development of nutritional guidance program for pregnant women at risk of giving birth to low birth weight infants.
Scientific Title
Development of nutritional guidance program for pregnant women at risk of giving birth to low birth weight infants.
Scientific Title:Acronym
Development of nutritional guidance program for pregnant women at risk of giving birth to low birth weight infants.
Region
| Japan |
Condition
Condition
Pregnant women without obstetric complications
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For pregnant women at risk of giving birth to low birth weight infant, continuous nutritional guidance will be provided during pregnancy, and the effectiveness of nutritional guidance will be verified from birth weight and weight gain during pregnancy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
weight gain during pregnancy
birth weight
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Individual nutritional diet guidance
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
12 weeks or more and less than 40 weeks of pregnancy
Singleton
Pregnant women who are scheduled to give birth at the facility where the survey is conducted
Key exclusion criteria
multiple births
obstetric complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Suzuki |
Organization
yamagata prefectural yonezawa university of nutrition sciences
Division name
Department of Health and Nutrition
Zip code
992-0025
Address
6-15-1 Tohrimachi, Yonezawa, Yamagata, JAPAN
TEL
0238-93-2925
m-suzuki@yone.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Suzuki |
Organization
yamagata prefectural yonezawa university of nutrition sciences
Division name
Department of Health and Nutrition
Zip code
992-0025
Address
6-15-1 Tohrimachi, Yonezawa, Yamagata, JAPAN
TEL
0238-93-2925
Homepage URL
m-suzuki@yone.ac.jp
Sponsor or person
Institute
Yamagata Prefectural Yonezawa University
Institute
Department
Personal name
Funding Source
Organization
Yamagata Prefectural Yonezawa University
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
yamagata prefectural yonezawa university
Address
6-15-1 torimati,yonezawasi,yamagata
Tel
0238-93-2925
m-suzuki@yone.ac.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
| 2022 | Year | 12 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056675
