UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032011
Receipt No. R000036456
Scientific Title Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Date of disclosure of the study information 2018/05/15
Last modified on 2019/04/08

* 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 Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Acronym Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Scientific Title Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Scientific Title:Acronym Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Region
Japan

Condition
Condition Scheduled cesarean section patient over 20 years old and scheduled after 37 weeks
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 As an abdominal wall retention at the time of cesarean section, it is classified into two group using a metal retractor and using a wound retractor. We evaluate wound infection, postoperative pain, and serum marker of amniotic fluid embolism, and compare and consider the difference between the two groups.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes marker of amniotic fluid embolism
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Use Alexis for abdominal wall grasping fixation during cesarean section.
Interventions/Control_2 Use conventional metal retractor for abdominal wall grasping fixation during cesarean section.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Scheduled cesarean section patient over 20 years old, after 37 weeks
Key exclusion criteria twin pregnancy,and serious maternal complication becomes the reason for cesarean section.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Kouitirou
Middle name
Last name Shimoya
Organization Kawasaki Medical University
Division name Department of Obstetrics and gynecology1
Zip code 7010192
Address Okayama Prefecture Kurashiki city Matsushima 577
TEL 086-462-1111
Email shimoya@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Mika
Middle name
Last name Sugihara
Organization Kawasaki Medical University
Division name Department of Obstetrics and gynecology1
Zip code 7010192
Address Okayama Prefecture Kurashiki city Matsushima 577
TEL 086-462-1111
Homepage URL
Email msugihara@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical University
Institute
Department

Funding Source
Organization Kawasaki Medical University
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 Kawasaki Medical University
Address Okayama Prefecture Kurashiki city Matsushima 577
Tel 0864621111
Email msugihara@med.kawasaki-m.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 05 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
2018 Year 11 Month 12 Day
Anticipated trial start date
2018 Year 11 Month 15 Day
Last follow-up date
2023 Year 11 Month 15 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 03 Month 30 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.