UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease
Title of the study (Brief title)	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

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	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	Kaoru Niimi
Organization	Nagoya Graduate University School of Medicine
Division name	Department of Obstetrics and Gynecology
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	Kaoru Niimi
Organization	Nagoya Graduate University School of Medicine
Division name	Department of Obstetrics and Gynecology
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

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015234