UMIN-CTR Clinical Trial

Public title

The study for accuracy of ultrasonographic diagnosis of placenta previa during second trimester.

Acronym

The study for accuracy of ultrasonographic diagnosis of placenta previa during second trimester.

Scientific Title

The study for accuracy of ultrasonographic diagnosis of placenta previa during second trimester.

Scientific Title:Acronym

The study for accuracy of ultrasonographic diagnosis of placenta previa during second trimester.

Region

Japan

Condition

Placenta previa

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To improve accuracy of ultrasound diagnosis for placenta previa in the second trimester.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Diagnostic accuracy for placenta previa.

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

(1) Pregnant women who visit to hospital between 20+0 and 24+6 weeks' gestation.
(2) Cases whose placenta is visualized via transvaginal ultrasonography on the uterine cervical os.
(3) Written informed consent form after giving detail information can be obtained. (In case patient is under 20 years old, this form must be also obtained from person in parent authority.)

Key exclusion criteria

(1) Multiple pregnancies.
(2) Cases received uterine cervical circlage operation in the current pregnancy period.
(3) Cases whose uterus has congenital anomaly or myoma in the uterine cervix or isthmus.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Shiro Kozuma

Organization

Tokyo University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

TEL

03-3815-5411

Email

hasejun@oak.dti.ne.jp

Name of contact person

1st name
Middle name
Last name	Junichi Hasegawa

Organization

Showa University School of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

Address

1-5-8 Hatanodai, Shinagawa-Ku, Tokyo, 142-8666, Japan

TEL

03-3781-8551

Homepage URL

Email

hasejun@oak.dti.ne.jp

Institute

Showa University School of Medicine, Department of Obstetrics and Gynecology

Institute

Department

Personal name

Organization

None

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

杏林大学医学部付属病院（東京都）、慶應義塾大学病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、順天堂大学医学部附属順天堂浦安病院（東京都）、昭和大学病院（東京都）、母子愛育会総合母子保健センター愛育病院（東京都）、帝京大学（東京都）、東京医科歯科大学医学部附属病院（東京都）、東京医科大学病院（東京都）、東京医科大学八王子医療センター（東京都）、東京慈恵会医科大学附属病院（東京都）、東京女子医科大学母子総合医療センター（東京都）、東京大学医学部附属病院（東京都）、東邦大学医療センター佐倉病院（千葉県）、日本医科大学付属病院（東京都）、日本医科大学付属武蔵小杉病院（神奈川県）、日本医科大学付属多摩永山病院（東京都）、日本赤十字社医療センター（東京都）、日本大学医学部附属板橋病院（東京都）、自治医科大学附属病院（栃木県）、独協医科大学病院（栃木県）、昭和大学藤が丘病院（神奈川県）、昭和大学横浜市北部病院（神奈川県）、岐阜大学（岐阜県）、久留米大学病院（福岡県）、慈恵医科大学附属柏病院（千葉県）

Date of disclosure of the study information

2013

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27174433

Number of participants that the trial has enrolled

Results

Results: We screened 9,341 patients, and 53 (0.6%) met the inclusion criteria. Nineteen cases with an open isthmus and 34 with a closed isthmus were followed. The accuracy for diagnosing placenta previa or a low-lying placenta at term was 94.7% in the open isthmus group and 26.5% in the closed isthmus group (p < 0.001). Elective or emergency Cesarean section was required in 100% of cases in the open isthmus group and 20.6% in the closed isthmus group (p < 0.001).

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

2012

Year

10

Month

10

Day

Date of IRB

Anticipated trial start date

2013

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2016

Year

04

Month

01

Day

Other related information

Multicenter prospective study
Case-control study

Registered date

2013

Year

04

Month

17

Day

Last modified on

2016

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012311