UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034008
Receipt number 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 13:10:44

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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

Obstetrics 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 or person

Institute

Kitasato University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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