UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035272
Receipt number R000040187
Scientific Title A prospective study analyzing the relationship between heart rate variability and maternal hypotension/ fetal bradycardia after combined spinal and epidural analgesia for labor analgesia
Date of disclosure of the study information 2019/01/04
Last modified on 2023/03/16 13:31:26

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Basic information

Public title

A prospective study analyzing the relationship between heart rate variability and maternal hypotension/ fetal bradycardia after 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 the relationship between heart rate variability and maternal hypotension/ fetal bradycardia after 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.This study questioned if baseline HRV measurements could be used as a non-invasive predictive tool to identify parturients at significant risk for hypotension and FHR abnormalities following CSEA.

Basic objectives2

Others

Basic objectives -Others

Changes in heart rate variability (liner and non-liner) 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

Heart rate variability rate change before and after spinal analgesia for labor. Comparison of heart rate variability in normotensive and hypotensive groups after analgesia.

Key secondary outcomes

The secondary endpoint is FHR abnormalities (late or variable decelerations) within 30 minutes after CSEA.


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

150


Research contact person

Name of lead principal investigator

1st name SHUNSUKE
Middle name
Last name HYUGA

Organization

Kitasato University

Division name

Anesthesiology, School of Medicine

Zip code

252-0375

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 SHUNSUKE
Middle name
Last name HYUGA

Organization

Kitasato University

Division name

Anesthesiology, School of Medicine

Zip code

2520375

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

The Kitasato Institute,Clinical Research Review Board

Address

1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa

Tel

042-778-8273

Email

rinri-n@kitasato-u.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

北里大学病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 04 Day


Related information

URL releasing protocol

https://www.kitasato-u.ac.jp/med/rinri/

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0959289X23000213

Number of participants that the trial has enrolled

85

Results

Between parturients showing FHR abnormalities (n = 19) and those showing reassuring FHR traces (n = 62). The area under the ROC curve (AUC) for predicting hypotension of the baseline low-frequency (LF)/high-frequency (HF) ratio was 0.677 (95% CI 0.55 to 0.80), and that of the ANI was 0.858 (95% CI 0.78 to 0.94). For predicting non-reassuring FHR patterns, the AUC of the LF/HF ratio was 0.77 (95% CI 0.65 to 0.89), and that of the ANI was 0.833 (95% CI 0.72 to 0.94).

Results date posted

2023 Year 03 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Normotensive pregnant women of American Society of Anesthesiologists physical status 2, scheduled for induction of labor, were included in the study. The exclusion criteria were chronic use of any medication (excluding prenatal vitamins), smoking, and comorbidities (e.g. hypertension, diabetes, thyroid disease, asthma), an abnormal FHR tracing, major fetal anomalies, fetal demise or heart disease, or any contraindication to neuraxial analgesia.

Participant flow

All pregnant women were informed of the study verbally, and they provided written informed consent for study participation before the onset of labor.

Adverse events

Nothing

Outcome measures

In the primary outcome analysis, patients were categorized into a normotensive or hypotensive group. For the secondary outcome analysis, patients were categorized into a normal FHR or FHR abnormalities group. The ECG recordings were analyzed using LabChart 8 software ADInstruments, Dunedin, New Zealand with commonly validated HRV metrics, including those covering the linear time and frequency domains: LF 0.04 0.15 Hz, HF 0.15 0.4 Hz, LFHF ratio, and standard deviations SDs of scattergrams one and two SD1, SD2, and SD1SD2 ratio. The ANI and HRV metrics, as well as relevant peri-operative metrics, were compared between the two groups. These comparisons were made before and after CSE initiation. Additionally, receiver operator characteristic ROC curves were generated using the LFHF ratio and the ANI values before CSE initiation for our primary and secondary endpoints and the area under the curve AUC values of the ROC curves with confidence intervals CIs were calculated. DeLongs test was used to compare the AUCs of the ANI and LFHF ratio for the calculated AUCs. The difference in preCSE VAS scores between the two groups was analyzed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 12 Month 28 Day

Date of IRB

2019 Year 01 Month 04 Day

Anticipated trial start date

2019 Year 01 Month 04 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1.Prospective observational study
2.January 2019 - December 2021
3.Recruitment of subjects:Pregnant women who is admitted to our hospital and meet the selection criteria.
4.We corect and analyse that liner and non-liner HRV,age, weight, height, BMI, gestational age, Visual analog scale of pain at the time of anesthesia enforcement (VASP), VASP after anesthesia enforcement, 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 supine position for 15 min before intrathecal analgesia and for 30 min after analgesia.


Management information

Registered date

2018 Year 12 Month 16 Day

Last modified on

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040187


Research Plan
Registered date File name

Research case data specifications
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Research case data
Registered date File name