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Recruitment status Terminated
Unique ID issued by UMIN UMIN000021581
Receipt No. R000024882
Scientific Title A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia
Date of disclosure of the study information 2016/03/25
Last modified on 2018/12/16

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Basic information
Public title A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia
Acronym Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
Scientific Title A prospective study analyzing heart rate variability with combined spinal and epidural analgesia for labor analgesia
Scientific Title:Acronym Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
Region
Japan

Condition
Condition Pregnancy
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to compare heart rate variability before and after spinal analgesia for women undergoing labor analgesia with combined spinal and epidural analgesia and to investigate the extent to which spinal analgesia affects autonomic nervous activity balance at induction of labor analgesia.
Basic objectives2 Others
Basic objectives -Others Changes in heart rate variability (mainly low-frequency: LF/high-frequency: HF) were compared as autonomic nervous activity balance at induction of labor analgesia.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes LF/HF rate change before and after spinal analgesia for labor.
Key secondary outcomes Comparison of LF/HF rate change before and after spinal analgesia between cases with and without fetal heart rate deceleration at induction of labor 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 Patients who requested labor analgesia with combined spinal and epidural analgesia and consented to participate in the study
Key exclusion criteria 1.If a labor analgesia with combined spinal and epidural analgesia was contraindicated because of hematologic diseases or other reasons
2.If the patient did not wish to undergo combined spinal and epidural analgesia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SHUNSUKE HYUGA
Organization Kitasato University
Division name Anesthesiology, School of Medicine
Zip code
Address 1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8606
Email shyuga@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name SHUNSUKE HYUGA
Organization Kitasato University
Division name Anesthesiology, School of Medicine
Zip code
Address 1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8606
Homepage URL
Email shyuga@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 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 Terminated
Date of protocol fixation
2016 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Prospective observational study
2.March 2016 - December 2018
3.Recruitment of subjects:Pregnant women who is admitted to our hospital and meet the selection criteria.
4.We corect and analyse that HRV,age, weight, height, BMI, gestational age, Visual analog scale of pain at the time of anesthesia enforcement (VASP), VASP after anesthesia enforcement, HF, LF, cold sensation loss or decrease in the scope of the post-anesthesia, non-invasive blood pressure, oxygen saturation, heart rate, fetal heart rate and uterine contraction interval and a strength.We use HRV analysis device. HRV was analyzed at 0,5,10,15, and 30 min after injections of analgesics in the lateral position.

Management information
Registered date
2016 Year 03 Month 23 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024882

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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