UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025511
Receipt No. 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 (Ver. 4)

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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
Obsterics 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
Email 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
Email schneider.yusuke@gmail.com

Sponsor
Institute Osaka Health Center and Research Institute for Maternal and Child Birth, Department of Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029362