UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060419 |
|---|---|
| Receipt number | R000069116 |
| Scientific Title | Positional invariance of continuous noninvasive blood pressure monitoring versus oscillometric cuff blood pressure measurement in term pregnancy: a prospective simultaneous-measurement study |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 10:18:18 |
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Basic information
Public title
Comparison of Positional Invariance Between Continuous Noninvasive and Oscillometric Cuff Blood Pressure Measurements in Term Pregnant Women: A Prospective Simultaneous-Measurement Study
Acronym
Positional Invariance Study Of Term pregnancy: continuous noninvasive vs cuff
Scientific Title
Positional invariance of continuous noninvasive blood pressure monitoring versus oscillometric cuff blood pressure measurement in term pregnancy: a prospective simultaneous-measurement study
Scientific Title:Acronym
SIM-BP-PI study
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will simultaneously measure blood pressure using continuous noninvasive blood pressure monitoring (cNIBP) and a noninvasive oscillometric cuff device in term pregnant women, and compare the Position Invariance Index (PII) between the two methods (cNIBP vs cuff) across six commonly used clinical positions: supine, left lateral, right lateral, hands-and-knees, sitting, and standing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Position invariance index (PII) of mean arterial pressure (MAP) for each device (cNIBP and the oscillometric cuff blood pressure monitor)
Key secondary outcomes
1. PII for systolic blood pressure (SBP) and diastolic blood pressure (DBP) (defined in the same manner as for MAP).
2. Position-specific absolute deviations for each device, i.e., the change from the supine value for each non-supine position.
3. Agreement between cNIBP and the oscillometric cuff blood pressure device for MAP measurements in each position.
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with ASA physical status II who are scheduled to undergo elective cesarean delivery at 37 weeks gestation or later and who provide written informed consent to participate in the study.
Key exclusion criteria
Pregnant women with a history of cardiac disease, hypertension, or arrhythmia.
Pregnant women with multiple gestation, threatened preterm labor, or fetal growth restriction and/or structural anomalies.
Pregnant women with abnormal vital signs on admission.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | SHUNSUKE |
| Middle name | |
| Last name | HYUGA |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
0427788111
shyuga@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | SHUNSUKE |
| Middle name | |
| Last name | HYUGA |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
0427788111
Homepage URL
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel
0427788111
rinrib@med.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1 Eligible pregnant women who are admitted to our hospital without the onset of labor for elective cesarean delivery or for induction of labor will be informed about the study using the written information sheet (Appendix) and asked to provide written informed consent to participate.
2 After consent is obtained, participants will rest in bed. A conventional noninvasive oscillometric cuff blood pressure monitor will be placed on the upper arm of the dominant arm, and a cNIBP sensor will be applied to a fingertip. The fingertip cNIBP device will be calibrated to heart level in advance according to the manufacturers instructions.
3 Blood pressure will be continuously assessed using both devices in each of the following six positions: supine; lateral decubitus (two conditions: with the dominant arm uppermost and with the dominant arm lowermost);sitting; standing; and hands-and-knees. Measurements will be continued for 5 minutes immediately after each position change. The cuff device will measure blood pressure at 2.5 minute intervals. For analysis,the blood pressure value at 5 minutes after the position change will be used,defined as follows:
cNIBP:the value immediately before the cuff device begins its measurement at 5 minutes after the position change.
Cuff device:the value obtained from the measurement initiated at 5 minutes after the position change.
4 The order of the six positions will be determined by computer-generated randomization using a statistical software program.
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069116
