UMIN-CTR Clinical Trial

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

fetal growth restriction
placenta accreta
pregnancy induced hypertension

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical University

Institute

Department

Personal name

Organization

Tokyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

06

Day

URL releasing protocol

Publication of results

Published

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

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 related information

None

Registered date

2016

Year

08

Month

06

Day

Last modified on

2019

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027083