UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027004
Receipt No. R000030858
Scientific Title Does implementation of a Shinshu University Surgical Safety Checklist for maternity reduce maternal complications due to massive blood loss?
Date of disclosure of the study information 2017/04/16
Last modified on 2017/05/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Does implementation of a Shinshu University Surgical Safety Checklist for maternity reduce maternal complications due to massive blood loss?
Acronym Does implementation of a Shinshu University Surgical Safety Checklist for maternity reduce maternal complications due to massive blood loss?
Scientific Title Does implementation of a Shinshu University Surgical Safety Checklist for maternity reduce maternal complications due to massive blood loss?
Scientific Title:Acronym Does implementation of a Shinshu University Surgical Safety Checklist for maternity reduce maternal complications due to massive blood loss?
Region
Japan

Condition
Condition Pregnant women who underwent a caesarean section due to premature separation of the placenta, placenta previa, placenta accreta, or hysterorrhexis
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to determine whether implementation of our checklist reduced maternal complications due to massive blood loss in caesarean sections
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement in the ratio of the Shock Index (SI) value which is determined the value between SI value at the time of leaving the operating room against that of maximum SI value during the operation.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Pregnant women who underwent a caesarean section due to premature separation of the placenta, placenta previa, placenta accreta, or hysterorrhexis between September 1, 2011 and December 31, 2016 in Shinshu University Hospital
Key exclusion criteria Pregnant women who were suffering from anti-phospholipid antibody syndrome, who had a history of blood clots and/or who were using anticoagulants
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Wakabayashi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Email waka0924@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Wakabayashi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Homepage URL
Email waka0924@shinshu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Resuscitology,
Shinshu University School of Medicine
Institute
Department

Funding Source
Organization N/A
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
Address
Tel
Email

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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 16 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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively collect data to analyze primary and secondary endpoints from clinical records and anesthesia records

Management information
Registered date
2017 Year 04 Month 16 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.