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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035153
Receipt No. R000039979
Scientific Title Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: dural puncture epidural versus combined spinal-epidural anesthesia (prospective non-randomized comparative study)
Date of disclosure of the study information 2019/01/01
Last modified on 2019/02/26

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Basic information
Public title Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: dural puncture epidural versus combined spinal-epidural anesthesia (prospective non-randomized comparative study)
Acronym Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: DPE vs CSEA (non-randomized comparative study)
Scientific Title Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: dural puncture epidural versus combined spinal-epidural anesthesia (prospective non-randomized comparative study)
Scientific Title:Acronym Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: DPE vs CSEA (non-randomized comparative study)
Region
Japan

Condition
Condition pregnancy
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the incidence of fetal bradycardia after induction of labor analgesia with CSEA and DPE.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incience of fetal bradycardia within 1hour after induction of labor analgesia
Key secondary outcomes mode of delivery,level of perineal laceration, evaluation of satisfaction after delivery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 At the timing of induction of labor analgesia, dura is punctured but no medication is administered into subarachnoid space with intervention group. 0.5% hyperbaric bupivacaine and 10mcg of fentanyl are administerd with historical control group.
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
20 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria age is 20 years old or older

primipara

Cervix dilation is 5cm or more at the timing of induction of labor

paper based informed consent is obtained before labor starts
Key exclusion criteria multipara

abnormal cardio tocogram at the timing of induction of labor

contraindication of epidural anesthesia

whom research director judged not qualified as research subject
Target sample size 870

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name SHOKO OKAHARA
Organization Juntendo University Hospital
Division name Anesthesiology
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Email Shoko0719@yahoo.com

Public contact
1st name of contact person
1st name
Middle name
Last name SHOKO OKAHARA
Organization Juntendo University Hospital
Division name Anesthegiology
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Homepage URL
Email Shoko0719@yahoo.com

Sponsor
Institute Juntendo University Hospital
department of anesthegiology
Institute
Department

Funding Source
Organization Juntendo University Hospital
department of anesthegiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 01 Month 01 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 06 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039979

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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