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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026378
Receipt No. 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

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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 Obsterics 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
Email 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
Email m-inoue@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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