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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034744
Receipt No. R000039610
Official scientific title of the study The establishment of the diagnostic method of fetal skeletal dysplasia using 3-dymensional computed tomography (3D-CT) and protocol making
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/01

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Basic information
Official scientific title of the study The establishment of the diagnostic method of fetal skeletal dysplasia using 3-dymensional computed tomography (3D-CT) and protocol making
Title of the study (Brief title) Diagnosis of fetal skeletal dysplasia using 3D-CT
Region
Japan

Condition
Condition fetal skeletal dysplasia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine 3D-CT imaging method to establish an accurate diagnosis of fetal skeletal dysplasia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fetal femur length, shape of long bones, Ossification of bones
Key secondary outcomes evaluateon of the postnatal whole bones

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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria the patient suspected fetal skeletal dysplasia using fetal ultrasound examination
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator Miyoko Waratani
Organization Kyoto Prefectural University of Medicine
Division name Obstetrics and Gynecology
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5560
Email mwara@koto.kpu-m.ac.jp

Public contact
Name of contact person Miyoko Waratani
Organization Kyoto Prefectural University of Medicine
Division name Obstetrics and Gynecology
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5560
Homepage URL
Email mwara@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 11 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information We investigated the prenatal diagnosis and postnatal definitive diagnosis for cases of fetal skeletal dysplasia to examine the efficacy of 3D-CT for prenatal diagnosis of fetal skeletal dysplasia.

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039610

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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