Unique ID issued by UMIN | UMIN000035272 |
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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 |
A prospective study analyzing the relationship between heart rate variability and maternal hypotension/ fetal bradycardia after combined spinal and epidural analgesia for labor analgesia
Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
A prospective study analyzing the relationship between heart rate variability and maternal hypotension/ fetal bradycardia after combined spinal and epidural analgesia for labor analgesia
Comparison of maternal heart rate variability before and after combined spinal and epidural analgesia
Japan |
Pregnancy
Obstetrics and Gynecology | Anesthesiology |
Others
NO
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.
Others
Changes in heart rate variability (liner and non-liner) were compared as autonomic nervous activity balance at induction of labor analgesia.
Confirmatory
Others
Not applicable
Heart rate variability rate change before and after spinal analgesia for labor. Comparison of heart rate variability in normotensive and hypotensive groups after analgesia.
The secondary endpoint is FHR abnormalities (late or variable decelerations) within 30 minutes after CSEA.
Observational
Not applicable |
Not applicable |
Female
Patients who requested labor analgesia with combined spinal and epidural analgesia and consented to participate in the study
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
150
1st name | SHUNSUKE |
Middle name | |
Last name | HYUGA |
Kitasato University
Anesthesiology, School of Medicine
252-0375
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
042-778-8606
shyuga@kitasato-u.ac.jp
1st name | SHUNSUKE |
Middle name | |
Last name | HYUGA |
Kitasato University
Anesthesiology, School of Medicine
2520375
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
042-778-8606
shyuga@kitasato-u.ac.jp
Kitasato University
Kitasato University
Other
The Kitasato Institute,Clinical Research Review Board
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
042-778-8273
rinri-n@kitasato-u.ac.jp
NO
北里大学病院(神奈川県)
2019 | Year | 01 | Month | 04 | Day |
https://www.kitasato-u.ac.jp/med/rinri/
Published
https://www.sciencedirect.com/science/article/pii/S0959289X23000213
85
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).
2023 | Year | 03 | Month | 16 | Day |
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.
All pregnant women were informed of the study verbally, and they provided written informed consent for study participation before the onset of labor.
Nothing
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.
Completed
2018 | Year | 12 | Month | 28 | Day |
2019 | Year | 01 | Month | 04 | Day |
2019 | Year | 01 | Month | 04 | Day |
2021 | Year | 12 | Month | 31 | Day |
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.
2018 | Year | 12 | Month | 16 | Day |
2023 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040187
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