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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023518
Receipt No. R000027083
Scientific Title The utility of ultrasound elastography in obstetrics and gynecology area
Date of disclosure of the study information 2016/08/06
Last modified on 2019/02/16

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Basic information
Public title The utility of ultrasound elastography in obstetrics and gynecology area
Acronym The utility of ultrasound elastography in obstetrics and gynecology area
Scientific Title The utility of ultrasound elastography in obstetrics and gynecology area
Scientific Title:Acronym The utility of ultrasound elastography in obstetrics and gynecology area
Region
Japan

Condition
Condition fetal growth restriction
placenta accreta
pregnancy induced hypertension
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Basically elastography ultrasonically evaluates the deformation ratio of tissues compressed by the same force.The utility of the pattern classification by color mapping has been already established in diseases in superficial organs, such as the mammary gland, prostate gland and thyroid gland areas, where are close to probes. In the liver, which is an underlying organ, the severity of hepatic fibrosis determined by biopsy also actually showed correlation with a color score by elastography, and this is being clinically applied for evaluation of hepatic fibrosis.As mentioned above, elastography is appreciated in various clinical disciplines, and clinical utilities including usage and evaluation scales of elastography are searched and studies in different areas in addition to the above pattern classification procedure by color mapping.
The frequency commonly used for elastography is equivalent to B mode, which is commonly used in clinical practice of obstetrics and whose safety to the human body has been established. Therefore, it is considered that elastography would become an invaluable clinical tool if clinical utility of elastography would be also confirmed in the obstetric area. However, there are still only few study reports about elastography in the obstetric area.
Accordingly, we developed two indices, placental index and HT score, using elastography to evaluate how the placenta hardness correlates with estimated fetus weight in this study. Furthermore, we examined how these indices correlate with histological evaluation based on pathological consideration of placenta after delivery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the Elasticity of the Placental Tissue Evaluated by Ultrasound Elastography and Fetal Growth Restriction (FGR)
Correlation between the Elasticity of the Placental Tissue Evaluated by Ultrasound Elastography and placenta accreta
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 Subjects were pregnant women when considered to be after placental formation
Key exclusion criteria pregnant women with a severe complication
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TOMOYA HASEGAWA
Organization Tokyo Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 6-7-1, Nishi-Shinjyuku, Shinjyuku, Tokyo, 160-0023, Japan
TEL +81-3-3342-6111
Email ppppq999@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name TOMOYA HASEGAWA
Organization Tokyo Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 6-7-1, Nishi-Shinjyuku, Shinjyuku, Tokyo, 160-0023, Japan
TEL +81-3-3342-6111
Homepage URL
Email ppppq999@gmail.com

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
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
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 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The average PI was 44.3 in the in utero SGA group, which was significantly higher than that in the normal group 8.8 during pregnancy. There was a significant correlation between the PI and z score for estimated fetal weight (EFW). Moreover, a significant positive correlation was observed between the PI and the z score of birth weight. Pathological ischemia findings of the placenta were identified in 67% of the HT score 3 group, representing 6 of the 9 patients, and in 20% of the HT score 1 group, representing only 3 of the 15 patients.
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 Completed
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 08 Month 06 Day
Last modified on
2019 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027083

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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