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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024938
Receipt No. R000028692
Scientific Title Investigation of safety and effect of Mom's Care
Date of disclosure of the study information 2016/11/21
Last modified on 2016/11/21

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Basic information
Public title Investigation of safety and effect of Mom's Care
Acronym Investigation of safety and effect of Mom's Care
Scientific Title Investigation of safety and effect of Mom's Care
Scientific Title:Acronym Investigation of safety and effect of Mom's Care
Region
Japan

Condition
Condition Wound of caesarean section
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of Mom's Care
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the following items 8 weeks and 20 weeks after the start of intervention.
Wound conditions: eczema, redness, itch, others
diagnosis: contact dermatitis, skin ulcer, others
Key secondary outcomes Incidence rate of hypertrophic scar and keloid scar

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Past Mom's care to the wound from 4 weeks after caesarean section.
1 time/day 20 weeks.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria A case of performing a caesarean section at the jikei university affiliated hospital
Key exclusion criteria A case with no consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Ito
Organization The jikei university school of medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Email yitoh2012@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Konishi
Organization The jikei university school of medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Homepage URL
Email akikonishi@jikei.ac.jp

Sponsor
Institute The jikei university school of medicine
Institute
Department

Funding Source
Organization Gyne Mom Co.Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 21 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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028692

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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