UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Title of the study (Brief title)	The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Region	Japan

Condition
Condition	Patients with condyloma acuminatum receiving the laser treatment during pregnancy from April 1st 2001 to March 31st 2014
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between the vertical transmission of human papilloma virus type 6 or 11 and the occurrence of JORRP
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety and efficacy
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	All condyloma acuminatum patients who received the laser treatment during pregnancy from April 1st 2001 to March 31st 2014
Key exclusion criteria	None
Target sample size	40

Research contact person
Name of lead principal investigator	Kei Kawana
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics and Gynecology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411(ext.33407)
Email	kkawana-tky@umin.org

Public contact
Name of contact person	Kei Kawana
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics and Gynecology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411(ext.33407)
Homepage URL
Email	kkawana-tky@umin.org

Sponsor
Institute	The University of Tokyo Hospital 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)

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 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 07 Day
Anticipated trial start date	2014 Year 07 Month 09 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	JORRP : Juvenile-onset recurrent respiratory papillomatosis HPV:Human papilloma virus We are going to collect the data in the medical records, for example, HPV genotyping of the infant. Those data will be processed according to the terms of privacy policy. If you do not want us to use your data, could you indicate non-concurrence to us until August 31st 2014.

Management information
Registered date	2014 Year 07 Month 09 Day
Last modified on	2017 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016886