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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | fetal tachycarrhythmia(supraventricular tachycadia, atrial flutter) | |||
Classification by specialty |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Because the accumulation of the cases delayed, we extended a registration period until December, 2017. |
Management information | |||||||
Registered date |
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Last modified on |
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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 |