UMIN-CTR Clinical Trial

Basic information
Public title	Pregnancy Outcomes of Exposure to Methimazole Study
Acronym	Pregnancy Outcomes of Exposure to Methimazole [POEM] Study
Scientific Title	Pregnancy Outcomes of Exposure to Methimazole Study
Scientific Title:Acronym	Pregnancy Outcomes of Exposure to Methimazole [POEM] Study
Region	Japan

Condition
Condition	Graves' disease
Classification by specialty	Endocrinology and Metabolism Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether the incidence of MMI embryopathy increase with methimazole exposure during the early stage of pregnancy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of methimazole embryopathy, including single or multiple prevalence of the followings : 1)choanal atresia, 2)esophageal atresia, 3)aplasia cutis congenita, 4)umbilical duct defects, 5)omphalocele
Key secondary outcomes	1)prevalence of major anomaly 2)pregnancy outcomes(rate of live births, etc) 3)frequency of abortions 4)prevalence of miscarriages 5)prevalence of stillbirth(>=22g.w.) 6)neonatal outcome(BBW, gestational age) 7)neonatal health state(whether to need medical treatment or/and NICU care) 8)method of delivery(caesarean section or vaginal delivery) 9)pregnancy complications(esp.S.E.due to antithyroidal drug,ex., liver injury with hospitalization; agranulocytosis)

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)methimazole(MMI) group Graves' pregnant women who took any dose of MMI,regardless of PTU use, during 1st trimester(~11gw6d), or by the time of nomination if they were nominated before 12gw. 2)propylthiouracil(PTU) group Graves' pregnant women who take any dose of PTU, but not MMI during 1st trimester, or by the time of nomination if they were nominated before 12gw. 3)non-ATD group Graves' pregnant women who did not take any dose of PTU or MMI during 1st trimester, or by the time of nomination if they were nominated before 12gw.
Key exclusion criteria	1) subjects who have the diseases to be managed with medication that may be related with teratogenicity or the diseases that may be related with it by themselves. 2) current moderate to heavy drinkers (>7 drink/week) after their pregnancy test was positive. 3) current moderate to heavy smokers (>=20/day) after their pregnancy test was positive. 4)pregnant women who were pointed out with fetus abnormalities by echography or amniocenthesis before their nomination.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Naoko Middle name Last name Arata
Organization	National Center for Child Health and Development, Tokyo, Japan
Division name	Maternal Medicine
Zip code	1578535
Address	Setagayaku,
TEL	03-5494-7151
Email	arata-n@ncchd.go.jp

Public contact
Name of contact person	1st name NAOKO Middle name Last name ARATA
Organization	National Center for Child Health and Development, Tokyo, Japan
Division name	Maternal Medicine
Zip code	1578535
Address	Setagayaku,
TEL	03-5494-7151
Homepage URL	http://www.ncchd.go.jp/kusuri/news_med/poemstudy.html
Email	arata-n@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	National Center for Child Health and Development, Tokyo, Japan MHLW(Japan)
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	National Center for Child Health and Development
Address	Okura 2-10-1, Setagayaku, Tokyo, Japan
Tel	0337056742
Email	arata-n@ncchd.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	妊娠と薬情報センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 11 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1996
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to analysis delay
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	No longer recruiting
Date of protocol fixation	2007 Year 12 Month 25 Day
Date of IRB	2007 Year 12 Month 25 Day
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: Prospective, multicenter, cohort study The duration of the registration:from January 1,2008 to December 31, 2014 Methods: Graves' disease who became pregnant were registered from several thyroid clinics at the Japan Drug Information Institute in Pregnancy. Pregnancy outcomes were collected from participants and related medical institutes by letter or mail or phone.

Management information
Registered date	2015 Year 12 Month 11 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023293