UMIN-CTR Clinical Trial

Basic information
Public title	A target screening for congenital cytomegalovirus infection in pregnant women and newborns
Acronym	A target screening for congenital cytomegalovirus infection
Scientific Title	A target screening for congenital cytomegalovirus infection in pregnant women and newborns
Scientific Title:Acronym	A target screening for congenital cytomegalovirus infection
Region	Japan

Condition
Condition	Congenital cytomegalovirus infection
Classification by specialty	Obsterics and gynecology Pediatrics Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of a new target screening for congenital cytomegalovirus infection in pregnant women and newborns.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive and negative predictive values, sensitivity and specificity of the target screening to detect congenital cytomegalovirus infection in pregnant women and newborns who have risk factors.
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	1 days-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Fever or flu-like symptoms during pregnancy 2 Threatened miscarriage and threatened premature labor 3 Ultrasound abnormality associated with congenital CMV infection 4 Preterm delivery at less than 34 weeks of gestation 5 Light for date newborn 6 Automated auditory brainstem response-refer
Key exclusion criteria	Congenita anomaly, multiple pregnancy
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Hideto Middle name Last name Yamada
Organization	Teine Keijinkai Hospital
Division name	Center for Recurrent Pregnancy Loss
Zip code	006-8555
Address	1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo 006-8555, Japan
TEL	0116818111
Email	yamada-hideto@keijinkai.or.jp

Public contact
Name of contact person	1st name Hajime Middle name Last name Ota
Organization	Teine Keijinkai Hospital
Division name	Obstetrics and Gynekcology
Zip code	006-8555
Address	1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo 006-8555, Japan
TEL	0116818111
Homepage URL
Email	ota-ha@keijinkai.or.jp

Sponsor
Institute	Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization	The Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teine Keijinkai Hospital, IRB
Address	1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo 006-8555, Japan
Tel	0116818111
Email	tkh-cr@keijinkai.or.jp

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	2021 Year 11 Month 04 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 22 Day
Date of IRB	2021 Year 10 Month 22 Day
Anticipated trial start date	2021 Year 10 Month 22 Day
Last follow-up date	2026 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 11 Month 04 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052479