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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004270
Receipt No. R000005120
Scientific Title Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Date of disclosure of the study information 2010/10/01
Last modified on 2019/04/03

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Basic information
Public title Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Acronym Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Scientific Title Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Scientific Title:Acronym Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Region
Japan

Condition
Condition fetal tachycarrhythmia(supraventricular tachycadia, atrial flutter)
Classification by specialty
Cardiology Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of transplacental anti-arrhythmic treatment for fetal tachycarrhythmias
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes sinus rhythm or fetal heart rate <180bpm (the half of 30 min fetal echocardiogram and/ or 40 min CTG )
Key secondary outcomes 1. IUFD
2. rate of preterm birth
3. rate of cesarean section
4. fetal heart rate, hydrops
5. neonatal arrhythmias
6. CNS findings in neonate
7. survival rate at 1 month
8. tachyarrhythmias at 1 month
(9.MRI at 1month(corrected))
(10.development at 1y 6m(corrected))
(11.development at 3y(corrected))

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 These antiarrhythmic agency are administered to pregnant women as treatment for fetal
supraventricular tachycardia with short VA interval
(start with 2nd for fetal hydrops)
1st. digoxin
2nd. digoxin+sotalol
3rd. digoxin+flecainide
These antiarrhythmic agency are administered to pregnant women as treatment for fetal
supraventricular tachycardia with long VA interval
1st. sotalol
2nd. flecainide
These antiarrhythmic agency are administered to pregnant women as treatment for fetal
atrial flutter. (start with 2nd for fetal hydrops)
1st. digoxin
2nd. digoxin+sotalol
3rd. digoxin+flecainide
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 Male and Female
Key inclusion criteria 1. sustained fetal tachycaarrhythmias with these diagnoses
1) supraventricular tachycardia with short VA interval
2) supraventricular tachycardia with short VA interval
3) atrial flutter
2.22w0d~36w6d
3.singleton
4.IC
Key exclusion criteria 1. impossible to obtain IC due to the mental problem
2. risk for maternal health (ex; allergic to anti-arrhythmic agency)
3. Dr's judgement
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasuki
Middle name
Last name Maeno
Organization Kurume University School of Medicine
Division name Department of Pediatrics
Zip code 830-0011
Address Kurume, Fukuoka
TEL +81-942-35-3311
Email yasukim@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Takekazu
Middle name
Last name Miyoshi
Organization National Cerebral and Cardiovascular Center
Division name Department of Perinatology and Gynecology
Zip code 565-8565
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL +81-6-6833-5012
Homepage URL http://en.fetusjapan.jp/
Email taijihin@ml.ncvc.go.jp

Sponsor
Institute National cerebral and cardiovascular center of Japan
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare of Japan (Health and Labour Science Research Grants for Clinical Research for New Medicine)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National cerebral and cardiovascular center of Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Ethics Committee of National Cerebral and Cardiovascular Center
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
Tel +81-6-6833-5012
Email plandiv@ml.ncvc.go.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 国立循環器病研究センター(大阪府)、久留米大学病院(福岡県)、大阪母子医療センター(大阪府)、国立成育医療研究センター(東京都)、神奈川県立こども医療センター(神奈川県)、筑波大学(茨城県)、東邦大学医療センター大森病院(東京都)、北海道大学病院(北海道)、兵庫県立こども病院(兵庫県)、長野県立こども病院(長野県)、静岡県立こども病院(静岡県)、神戸市立医療センター中央市民病院(兵庫県)、三重大学病院(三重県)、岡山医療センター(岡山県)、大阪大学病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 01 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629695/
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 Completed
Date of protocol fixation
2010 Year 09 Month 13 Day
Date of IRB
2010 Year 07 Month 16 Day
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2017 Year 05 Month 09 Day
Date of closure to data entry
2018 Year 05 Month 31 Day
Date trial data considered complete
2018 Year 06 Month 21 Day
Date analysis concluded
2018 Year 07 Month 10 Day

Other
Other related information Because the accumulation of the cases delayed, we extended a registration period until December, 2017.

Management information
Registered date
2010 Year 09 Month 27 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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