UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026378 |
|---|---|
| Receipt number | R000030273 |
| Scientific Title | Clinical study of transplacental anti-arrythmic treatment for fetal tachyarrythmias |
| Date of disclosure of the study information | 2017/03/03 |
| Last modified on | 2018/05/09 16:52:40 |
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Basic information
Public title
Clinical study of transplacental anti-arrythmic treatment for fetal tachyarrythmias
Acronym
Clinical study of transplacental anti-arrythmic treatment for fetal tachyarrythmias
Scientific Title
Clinical study of transplacental anti-arrythmic treatment for fetal tachyarrythmias
Scientific Title:Acronym
Clinical study of transplacental anti-arrythmic treatment for fetal tachyarrythmias
Region
| Japan |
Condition
Condition
Fetal tachyarrythmia (Supraventricular tachycardia, Atrial flutter)
Classification by specialty
| Cardiology | Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy and safety of transplacental anti-arrythmic treatment for fetal tachyarrythmias
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
disappearance of fetal tachyarrythmias in more than half of 30min fetal echocardiogram and/or 40min cardiotocogram
Key secondary outcomes
1 Intrauterine Fetal Death
2 Rate of preterm birth
3 Rate of cesarean section
4 Improvement of fetal heart rate and/or fetal hydrops
5 Neonatal arrythmias
6 CNS findings in neonate
7 Survival rate at 1 month
8 Tachyarrythmias at 1 month
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 anti-arrythmic agent are administered to pregnant women as treatment for fetal supraventricular tachycardia with short VA interval or atrial flutter. Administration is started with 2nd for fetal hydrops. If the administration of digoxin is ineffective, digoxin is possible to be discontinued.
1st. digoxin
2nd. digoxin and sotalol
3rd. digoxin and flecainide
These anti-arrythmic agent are administered to pregnant women as treatment for fetal supraventricular tachycardia with long VA interval.
1st. sotalol
2nd. 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 tachyarrythmias
2 gestational age 22w0d~36w6d
3 singleton
4 Informed consent has been obtained from patient
Key exclusion criteria
1 it is impossible to obtain informed consent due to the mental problem
2 the treatment causes serious risk for mother's health
3 Doctor judged inappropriate for the treatment
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maki Inoue |
Organization
Gunma University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Maebashi, Gunma
TEL
+81-27-220-8429
m-inoue@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Inoue |
Organization
Gunma University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Maebashi, Gunma
TEL
+81-27-220-8429
Homepage URL
m-inoue@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2018 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030273
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/05/07 | 胎児不整脈 介入研究実施作成指針３ 2017年４月.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/05/09 | 胎児頻脈性不整脈 新生児CRF.xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/05/09 | 胎児頻脈性不整脈 新生児CRF.xls |
