UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053001 |
|---|---|
| Receipt number | R000060462 |
| Scientific Title | Effect of Labor Epidural Analgesia on Mode of Delivery |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2025/03/26 14:27:31 |
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Basic information
Public title
Effect of Labor Epidural Analgesia on Mode of Delivery
Acronym
Effect of Labor Epidural Analgesia on Mode of Delivery
Scientific Title
Effect of Labor Epidural Analgesia on Mode of Delivery
Scientific Title:Acronym
Effect of Labor Epidural Analgesia on Mode of Delivery
Region
| Japan |
Condition
Condition
women in the peripartum period
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure whether labor epidural analgesia increases the rate of emergency cesarean delivery
Basic objectives2
Others
Basic objectives -Others
We investigate whether labor epidural analgesia influences the indication for emergency caesarean section.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mode of Delivery (Vaginal Delivery or Cesarean Section)
Key secondary outcomes
We investigate differences of the emergency cesarean delivery rate between data from January 2015 to July 2018 and August 2018 to December 2021. We also look for factors associated with emergency cesarean delivery other than labor epidural analgesia.
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
Women who delivered during observational period
Key exclusion criteria
Women indicated for elective cesarean section
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Wakata |
Organization
Adachi Hospital
Division name
Department of Anesthesia
Zip code
604-0837
Address
Kagiya-Cho 481, Nakagyo-Ku, Kyoto-City, Kyoto
TEL
0752217431
wakata@adachi-hospital.com
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Wakata |
Organization
Adachi Hospital
Division name
Department of Anesthesia
Zip code
604-0837
Address
Kagiya-Cho 481, Nakagyo-Ku, Kyoto-City, Kyoto
TEL
0752217431
Homepage URL
https://www.adachi-hospital.com/wp-content/uploads/4c10f42e798f7e6d9bf1b9b029bd7c25.pdf
wakata@adachi-hospital.com
Sponsor or person
Institute
Adachi Hospital
Institute
Department
Personal name
Ryuichi Wakata
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
Kagiya-Cho 481, Nakagyo-Ku, Kyoto-City, Kyoto
Tel
0752217431
wakata@adachi-hospital.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
| 2023 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.ejog.org/article/S0301-2115%2825%2900049-1/
Publication of results
Published
Result
URL related to results and publications
https://www.ejog.org/article/S0301-2115%2825%2900049-1/
Number of participants that the trial has enrolled
5849
Results
Of 5849 deliveries from 1 August 2018 until 31 December 2021, 1,433 (24.5%) involved labor epidural analgesia. Of These, 203 (14.2%) involved unintended cesarean section, less than that in the non-labor epidural analgesia group (22.2%) (hazard ratio: 0.47; 95% confidence interval: 0.41 - 0.55, p < 0.001)
Results date posted
| 2025 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
women in labour (n = 11,792) between 1 January 2015 and 31 December 2021
Participant flow
The data was elected retrospectively from electronic record.
Adverse events
Nothing.
Outcome measures
Cesarean section
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 05 | Month | 01 | Day |
Other
Other related information
Applicable period of study data: January 1, 2015 to December 31, 2021
Study subjects: Patients who delivered at our hospital during the above period
Subject data: Age, height, pre-pregnancy weight, pre-delivery weight, number of previous clinical pregnancies, number of previous clinical births, smoking history, type of infertility treatment, history, mode of delivery, reason for indication for cesarean section, presence or absence of labor epidural analgesia, onset of labor, duration of the first stage of labor, duration of the second stage of labor, date of birth, duration of labor epidural analgesia, Apgar score of the infant, sex of the infant, height of the infant, weight of the infant, presence or absence of episiotomy, degree of perineal laceration
Management information
Registered date
| 2023 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060462
