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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034008
Receipt No. R000038513
Scientific Title Comparison of the blood pressure at rest and pre-anesthetic setting in pregnant women undergoing cesarean delivery
Date of disclosure of the study information 2018/09/15
Last modified on 2019/08/03

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Basic information
Public title Comparison of the blood pressure at rest and pre-anesthetic setting in pregnant women undergoing cesarean delivery
Acronym Comparison of the blood pressure at rest and pre-anesthetic setting in pregnant women undergoing cesarean delivery
Scientific Title Comparison of the blood pressure at rest and pre-anesthetic setting in pregnant women undergoing cesarean delivery
Scientific Title:Acronym Comparison of the blood pressure at rest and pre-anesthetic setting in pregnant women undergoing cesarean delivery
Region
Japan

Condition
Condition Pregnant women undergoing cesarean delivery with spinal anesthesia
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the correlation between blood pressure measured at rest and just before anesthesia in pregnant women undergoing cesarean delivery with spinal anesthesia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the correlation between blood pressure measured at rest and just before anesthesia
Key secondary outcomes factors which influence the difference of blood pressure between measured at rest and just before anesthesia

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Blood pressure measurement
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 pregnant women whose gestational age is 37 weeks and over
singleton
elective cesarean delivery with spinal anesthesia

Key exclusion criteria contraindication for spinal anesthesia
multiple pregnancy
gestational age is 36 weeks and less
hypertensive disorders of pregnancy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Hosokawa
Organization Kitasato University School of medicine
Division name Department of Anesthesiology
Zip code 252-0375
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city
TEL 0427788111
Email yhoso@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Hosokawa
Organization Kitasato University School of Medicine
Division name Depertment of anesthesiology
Zip code 252-0375
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city
TEL 0427788111
Homepage URL
Email yhoso@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization none
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 Kitasato University Medical Ethics Organization
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city
Tel 0427788111
Email rinri@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
2018 Year 09 Month 15 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 Completed
Date of protocol fixation
2018 Year 09 Month 15 Day
Date of IRB
2018 Year 09 Month 15 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 03 Day
Last modified on
2019 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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