UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021581
Receipt number 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 20:34:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Obstetrics 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 or person

Institute

Kitasato University

Institute

Department

Personal name



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

Value
https://center6.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