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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015177
Receipt No. R000015234
Scientific Title The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease
Date of disclosure of the study information 2014/09/16
Last modified on 2016/09/20

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Basic information
Public title The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease
Acronym The effect of second evacuation for hydatidiform mole
Scientific Title The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease
Scientific Title:Acronym The effect of second evacuation for hydatidiform mole
Region
Japan

Condition
Condition hydatidiform mole
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Japanese standard treatment for hydatidiform mole is peforming a second curettage one week after first evacuation. The aim is investigating that the ratio of post-molar trophoblastic diseases is not worse without a second curettage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The ratio of post-molar trophoblastic diseases is not worse without a second curettage.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria clinical diagnosis by ultrasound and serum level of hCG is hydatidiform mole
Key exclusion criteria younger than 20 years old
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaoru Niimi
Organization Nagoya Graduate University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2261
Email kaorun@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Niimi
Organization Nagoya Graduate University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2261
Homepage URL
Email kaorun@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Graduate University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Nagoya Graduate University School of Medicine
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
2014 Year 09 Month 16 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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information follow-up for developing to trophoblastic tumors after an evacuation by measuring serum hCG

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2016 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015234


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