UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063496 |
|---|---|
| Receipt number | R000072671 |
| Scientific Title | Comparison of Maternal and Neonatal Outcomes Between Continuous Epidural Infusion and Programmed Intermittent Epidural Bolus for Labor Analgesia: A Single-Center Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 14:24:32 |
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Basic information
Public title
Comparison of Maternal and Neonatal Outcomes Between Continuous Epidural Infusion and Programmed Intermittent Epidural Bolus for Labor Analgesia: A Single-Center Retrospective Cohort Study
Acronym
Maternal and Neonatal Outcomes of Continuous Epidural Infusion Versus Programmed Intermittent Epidural Bolus in Labor Analgesia
Scientific Title
Comparison of Maternal and Neonatal Outcomes Between Continuous Epidural Infusion and Programmed Intermittent Epidural Bolus for Labor Analgesia: A Single-Center Retrospective Cohort Study
Scientific Title:Acronym
CEI/PIEB retrospective cohort study
Region
| Japan |
Condition
Condition
Pregnant women aged 18 years or older who received epidural analgesia for labor between January 1, 2020 and December 31, 2025, and their newborns.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively compare maternal and neonatal outcomes of labor epidural analgesia before and after the transition from continuous epidural infusion (CEI) to programmed intermittent epidural bolus (PIEB), and to evaluate differences between the two periods.teiou
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of cesarean delivery (conversion from labor to cesarean delivery)
Key secondary outcomes
Total dose of local anesthetic
Rate of vacuum-assisted delivery
Duration of the second stage of labor
Blood loss during delivery
Edinburgh Postnatal Depression Scale (EPDS) score
Neonatal Apgar scores at 1 and 5 minutes
Umbilical artery blood pH
Feeding method (breastfeeding, formula feeding, or mixed feeding)
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
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women aged 18 years or older who received labor epidural analgesia between January 1, 2020, and December 31, 2025, and their newborns.
Key exclusion criteria
Stillbirth; multiple pregnancy; substantially missing medical record data required for the study; and refusal of participation through the opt-out document.
Target sample size
832
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Hirai |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
0734410611
akihri@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Hirai |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
0734410611
Homepage URL
akihri@wakayama-med.ac.jp
Sponsor or person
Institute
School of Medicine, Wakayama Medical University
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
Wakayama Medical University Ethics Review Committee
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
Tel
0734410897
wa-rinri@wakayama-med.ac.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
| 2026 | Year | 11 | Month | 02 | 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
832
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
| 2026 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study using medical records, with no new intervention or follow-up. Two consecutive periods are compared: the CEI period (2020-2022) and the PIEB period (2023-2025). The target sample size of 832 is the total of 416 mothers and 416 neonates (416 deliveries), and no formal sample size calculation was performed. An opt-out notice is provided so that eligible participants have the opportunity to decline participation in the study.
Management information
Registered date
| 2026 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072671
