UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027004
Receipt number 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 2019/11/17 14:32:47

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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

Obstetrics 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 Ryo
Middle name
Last name Wakabayashi

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-8621

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 Ryo
Middle name
Last name Wakabayashi

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2670

Homepage URL


Email

waka0924@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine, Department of Anesthesiology and Resuscitology

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

Shinshu University School of Medicine, Institutional Review Board

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-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

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

Terminated

Date of protocol fixation

2015 Year 07 Month 07 Day

Date of IRB

2015 Year 07 Month 07 Day

Anticipated trial start date

2015 Year 07 Month 08 Day

Last follow-up date

2017 Year 06 Month 22 Day

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

2019 Year 11 Month 17 Day



Link to view the page

Value
https://center6.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