UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025511 |
|---|---|
| Receipt number | R000029362 |
| Scientific Title | Retrospective study of epidural labor and its effect on mode of delivery in Japan |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2019/07/11 18:41:28 |
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Basic information
Public title
Retrospective study of epidural labor and its effect on mode of delivery in Japan
Acronym
Retrospective study of epidural labor and its effect on mode of delivery in Japan
Scientific Title
Retrospective study of epidural labor and its effect on mode of delivery in Japan
Scientific Title:Acronym
Retrospective study of epidural labor and its effect on mode of delivery in Japan
Region
| Japan |
Condition
Condition
Pregnant who delivered in our institute
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epidural anesthesia reduces pain during labor. Although, some meta-analysis performed aboard have shown that epidural labor does not negatively affect the course of labor, it is still unclear for Japanese women. The objective of this research is to study the effect of epidural anesthesia in Japanese population.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mode of delivery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant who underwent labor in our institute during the study period
Key exclusion criteria
Artificial abortion
Intrapartum fetus death
gestational week less than 36weeks
multiple fetus
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Naito |
Organization
Osaka Health Center and Research Institute for Maternal and Child Birth
Division name
Department of Anesthesiology
Zip code
5941101
Address
840 Murodo-cho, Izumi-shi, Osaka, Japan
TEL
0725-56-1220
schneider.yusuke@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Naito |
Organization
Osaka Health Center and Research Institute for Maternal and Child Birth
Division name
Department of Anesthesiology
Zip code
5941101
Address
840 Murodo-cho, Izumi-shi, Osaka, Japan
TEL
0725-56-1220
Homepage URL
https://www.mch.pref.osaka.jp/center/activities/rinri_05_28.html
schneider.yusuke@gmail.com
Sponsor or person
Institute
Osaka Health Center and Research Institute for Maternal and Child Birth, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nara Medical University
Name of secondary funder(s)
Department of Anesthesiology
IRB Contact (For public release)
Organization
Osaka Health Center and Research Institute for Maternal and Child Birth, Department of Anesthesiology
Address
840 Murodo-cho, Izumi-shi, Osaka, Japan
Tel
0725-56-1220
schneider.yusuke@gmail.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
| 2017 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://jaclinicalreports.springeropen.com/articles/10.1186/s40981-019-0260-z
Publication of results
Published
Result
URL related to results and publications
https://jaclinicalreports.springeropen.com/articles/10.1186/s40981-019-0260-z
Number of participants that the trial has enrolled
2632
Results
Conclusion
Use of LEA did not increase the rate of cesarean section when analyzed by propensity score-matched analysis in our institute.
Results date posted
| 2019 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pregnant women who delivered the child at gestational age of 36weeks or older
Participant flow
Out of 4000 pregnant women, women who met exclusion criteria were excluded. Rest of the women were divided into two groups (labor with/without epidural analgesia). We performed propensity score matching to analyze the results.
Adverse events
None
Outcome measures
Mode of Delivery, Duration of labor, neonatal outcomes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the pregnant meeting inclusion criteria, following variables are collected.
Characteristics ( height, weight, complication), onset of labor, course of labor (duration of first and second stage of labor, mode of delivery), outcome of the infants
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | 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=R000029362
