UMIN-CTR Clinical Trial

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
Email	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
Email	h-ohtani@shizuokamind.org

Sponsor
Institute	The Japanese Epilepsy Society
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036103