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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010527
Receipt No. R000012311
Scientific Title The study for accuracy of ultrasonographic diagnosis of placenta previa during second trimester.
Date of disclosure of the study information 2013/04/17
Last modified on 2016/10/19

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Basic information
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
Condition Placenta previa
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Diagnostic accuracy for placenta previa.
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 (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

Research contact person
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

Public contact
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

Sponsor
Institute Showa University School of Medicine, Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization None
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 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)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information Multicenter prospective study
Case-control study

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012311

Research Plan
Registered date File name
2016/04/17 JOPP-3-前置胎盤診断計画書1010倫理委員会.docx

Research case data specifications
Registered date File name
2016/04/17 症例シート.docx

Research case data
Registered date File name
2016/04/17 JOPP3出血追加.xls


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