UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062611 |
|---|---|
| Receipt number | R000071615 |
| Scientific Title | Maternal Arterial Pressure and Symptoms during Cesarean Delivery under Neuraxial Anesthesia: A Multicenter Prospective Observational Study to Define Clinically Relevant Hypotension (MAPS Study) |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/19 11:01:58 |
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Basic information
Public title
Maternal Arterial Pressure and Symptoms during Cesarean Delivery under Neuraxial Anesthesia: A Multicenter Prospective Observational Study to Define Clinically Relevant Hypotension (MAPS Study)
Acronym
MAPS Study
Scientific Title
Maternal Arterial Pressure and Symptoms during Cesarean Delivery under Neuraxial Anesthesia: A Multicenter Prospective Observational Study to Define Clinically Relevant Hypotension (MAPS Study)
Scientific Title:Acronym
MAPS Study
Region
| Japan |
Condition
Condition
cesarean delivery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the continuous association between the lowest mean arterial pressure (MAP) from the initiation of neuraxial anesthesia to delivery and intraoperative nausea and vomiting in women undergoing cesarean delivery, using restricted cubic spline analysis. We further aim to identify a clinically meaningful MAP threshold associated with maternal symptoms and thereby establish a clinically relevant definition of maternal hypotension during cesarean delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between the lowest mean arterial pressure (MAP) from the initiation of neuraxial anesthesia to delivery and the occurrence of intraoperative nausea and vomiting (IONV).
Key secondary outcomes
The association between the lowest MAP from the initiation of neuraxial anesthesia to delivery and umbilical arterial blood pH.
The association between the percentage decrease in intraoperative blood pressure from baseline blood pressure measured on the ward and in the operating room and the occurrence of IONV.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women undergoing cesarean delivery under neuraxial anesthesia who meet the following criteria:
1. Gestational age >_ 36 weeks
2. Singleton or twin pregnancy
Key exclusion criteria
1. Conversion to general anesthesia
2. Intrapartum emergency cesarean delivery
Target sample size
707
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graguate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka, Japan
TEL
0666452186
takataka0061@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
Homepage URL
takataka0061@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University Graguate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee of Osaka Metropolitan University Hospital
Address
Abeno Medix 6F, 1-2-7 Asahimachi, Abeno-ku, Osaka 545-0051, Japan
Tel
0666453456
gr-a-knky-ethics@omu.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 | 08 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the association between nadir mean arterial pressure before delivery and intraoperative nausea and vomiting during elective cesarean delivery under neuraxial anesthesia using restricted cubic spline analysis, and to identify a clinically meaningful threshold for defining maternal hypotension.
Management information
Registered date
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071615
