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Recruitment status
Unique ID issued by UMIN UMIN000024472
Receipt No. R000028158
Scientific Title A prospective study for the expectant management pf placental polyp
Date of disclosure of the study information 2016/12/01
Last modified on 2017/04/20

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Basic information
Public title A prospective study for the expectant management pf placental polyp
Acronym The expectant management study
Scientific Title A prospective study for the expectant management pf placental polyp
Scientific Title:Acronym The expectant management study
Region
Japan

Condition
Condition placental popyp
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The uterine artery embolization is performed for the prevention of blood loss, however, there are some broblem as radiation exposure or fertility disorders. To avoid the excess treatment, we propose the expectant managemnet for placental polyp using PDCS assessment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Th eplacental polyp is examined mass diameter and PDCS using ultrasonography. We check Hb and hCG level in blood test. The patients take the examinations once a week. The expctant management protocol aim that placental polyp show PDCS level1 and hCG level show under-sensitive.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 In case of PDCS up-regulation or increasing of hCG level during the expectant management for placental polyp, we consider the intervention with uterine artery embloization after differential diagnosis of trophoblastic disease. TCR procedure is considered in case the remaining of mass over 2 cm after embolization.
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 The patients, who are diagnosed placental polyp after delivery or termination of pregnancy. There is no preference of the duration after the termination and mass diameter.
Key exclusion criteria The case white the physician judge to be inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira IWASE
Organization Nagoya University Hospital
Division name Center for Maternal-Neonatal Care
Zip code
Address Tsurumai 65, Showa, Nagoya city JAPAN
TEL 052-744-2261
Email akiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko TAKIKAWA
Organization Nagoya University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Tsurumai 65, Showa, Nagoya city JAPAN
TEL 052-744-2261
Homepage URL
Email stone24@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
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 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2017 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028158

Research Plan
Registered date File name
2017/04/20 研究計画書(胎盤ポリープ).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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