UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004270 |
|---|---|
| Receipt number | 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 12:24:25 |
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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 | Obstetrics 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
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/
taijihin@ml.ncvc.go.jp
Sponsor or person
Institute
National cerebral and cardiovascular center of Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005120
