UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034135 |
|---|---|
| Receipt number | R000036103 |
| Scientific Title | Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development |
| Date of disclosure of the study information | 2018/10/09 |
| Last modified on | 2020/09/15 10:09:25 |
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Basic information
Public title
Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development
Acronym
Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development(JES-AEDs-PG)
Scientific Title
Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development
Scientific Title:Acronym
Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development(JES-AEDs-PG)
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the teratogenicity of antiepileptic drugs (To examine the differences of teratogenicity due to type, dose, and blood concentration by each antiepileptic drug, single agent or multidrug).
Basic objectives2
Others
Basic objectives -Others
o examine the differences of teratogenicity due to type, dose, and blood concentration by each antiepileptic drug, single agent or multidrug
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of malformation (shall be evaluated by single and multidrug administration respectively. When the number of cases that can be statistically processed is registered, examinations by dosage and blood concentration for each antiepileptic drug will be performed.)
Key secondary outcomes
Outcome after pregnancy (spontaneous abortion, stillbirth, perinatal death, birth)
Oral antiepileptic drug
Blood concentration of oral antiepileptic drug
Maternal seizure
Folic acid amount in blood
Incidence rate of malformation
Health condition of infants
Breastfeeding
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Female
Key inclusion criteria
(1) Pregnant women with epilepsy
(2) Pregnant women with unknown outcome of pregnancy (abortion, miscarriage, stillbirth, birth) at the time of consent
Key exclusion criteria
(1) Those judged as inappropriate for participation in this study by the principal investigator/sub-investigators
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Inoue |
Organization
National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
The president of the hospital
Zip code
420-8688
Address
886 Urushiyama , Aoi-ku, Shizuoka-shi, Shizuoka, 420-8688, Japan
TEL
054-245-5446
yinoue-jes@umin.net
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Ohtani |
Organization
National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Division of clinical Research,Pediatrics
Zip code
420-8688
Address
886 Urushiyama , Aoi-ku, Shizuoka-shi, Shizuoka, 420-8688, Japan
TEL
054-245-5446
Homepage URL
h-ohtani@shizuokamind.org
Sponsor or person
Institute
The Japanese Epilepsy Society
Institute
Department
Personal name
Funding Source
Organization
JES Pregnancy Registry Fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japan Epilepsy Society
Address
4-6-15 Ogawahigashi-chyo , Kodaira-shi , Tokyo, 187-0031, Japan
Tel
042-345-2522
jes-oas@umin.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will start at the time of consent of the first subject and ends at the time of completion of the last observation date, discontinuation of treatment, or the last hospital visit (the day when the principal investigator/sub-investigators cannot contact the patient) of the last subject.
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036103
