UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055199 |
|---|---|
| Receipt number | R000059725 |
| Scientific Title | The effect of changing hospital diets during labour |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/04/25 15:38:43 |
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Basic information
Public title
The effect of changing hospital diets during labour
Acronym
The effect of changing hospital diets during labour
Scientific Title
The effect of changing hospital diets during labour
Scientific Title:Acronym
The effect of changing hospital diets during labour
Region
| Japan |
Condition
Condition
laboring patients
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on the labour depends on the different types of the hospital diets, between newly developed light meal "laboring diet" and "normal diet for pregnant patients".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient satisfaction regarding the labour and the diet provided.
Key secondary outcomes
Nausea and vomiting (during and after the labour), the amount of the diet taken(during and after the labour), ultrasound examination of gastric antrum, delivery time, amount of bleeding, Cesarean section rate, instrumental delivery rate, recovery after the delivery (ambulation), baby's APGAR and blood sugar, evaluation by the midwives in charge regarding the diet taken
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The patients will be provided newly developed diet for patient in labour. This intervention will continue during the entire labour. There will be no intervention except for the diet. All the patients will be allowed to drink clear water without restriction. The management of the labour will be the same as per the standard of our hospital.
Interventions/Control_2
The patients will be provided normal hospital diet for pregnant patient. This intervention will continue during the entire labour. There will be no intervention except for the diet. All the patients will be allowed to drink clear water without restriction. The management of the labour will be the same as per the standard of our hospital.
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
Healthy patients (ASA lower than 2) expecting for vaginal delivery
Key exclusion criteria
Patients with diabetes, Patients who have strict diet restriction, Patients with severe complications (ASA greater than 3)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Department of Anesthesiology
Zip code
1308575
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL
0336336151
hirano-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Departmeht of Anesthesia
Zip code
1308575
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL
0336336151
Homepage URL
a-hirano@juntendo.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Bokutoh Hospital
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
Tel
0336336151
bo_rinsyo_kenkyu@tmhp.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
| 2024 | Year | 08 | Month | 09 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059725
