UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059285 |
|---|---|
| Receipt number | R000067521 |
| Scientific Title | Effects of Epidural Analgesia on Neonatal Outcomes |
| Date of disclosure of the study information | 2025/10/04 |
| Last modified on | 2025/10/03 22:14:38 |
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Basic information
Public title
Effects of Epidural Analgesia on Neonatal Outcomes
Acronym
Effects of Epidural Analgesia on Neonatal Outcomes
Scientific Title
Effects of Epidural Analgesia on Neonatal Outcomes
Scientific Title:Acronym
Effects of Epidural Analgesia on Neonatal Outcomes
Region
| Japan |
Condition
Condition
Labor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether epidural analgesia affects neonatal NICU admission.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NICU adission
Key secondary outcomes
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
| 18 | years-old | < |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant women who delivered at our hospital between 37 and 40 weeks of gestation and their newborns
Key exclusion criteria
Deliveries by cesarean section and newborns with congenital anomalie
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Wakata |
Organization
Adachi Hospital
Division name
Department of Anesthesiology
Zip code
604-0837
Address
Kyoto-Fu, Kyoto-Shi, Nakagyo-Ku, Kagiya-Chou 488
TEL
075-221-7431
wakata@adachi-hospital.com
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Wakata |
Organization
Adachi Hospial
Division name
Department of Anesthesiology
Zip code
604-0837
Address
Kyoto-Fu, Kyoto-Shi, Nakagyo-Ku, Kagiya-Chou 488
TEL
075-221-7431
Homepage URL
wakata@adachi-hospital.com
Sponsor or person
Institute
Adachi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Adachi Hospital
Address
Kyoto-Fu, Kyoto-Shi, Nakagyo-Ku, Kagiya-Chou 488
Tel
075-221-7431
tinoue@adachi-hopital.com
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
| 2025 | Year | 10 | Month | 04 | 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
1278
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
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection items for investigating the effects of epidural analgesia on newborns: Age, height, pre-pregnancy weight, pre-delivery weight, number of previous clinical pregnancies, number of previous clinical deliveries, smoking history, type of fertility treatment, medical history, mode of delivery, indication for C-section, presence or absence of epidural analgesia, date and time of labor onset, duration of the first stage of labor, duration of the second stage of labor, date and time of delivery, infant's Apgar score, infant's sex, infant's length, infant's weight, presence or absence of LBW (Low Birth Weight), presence or absence of SGA (Small for Gestational Age), presence or absence of NICU admission, duration of NICU admission, reason for NICU admission, severity of respiratory distress.
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067521
