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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020164
Receipt No. R000023293
Scientific Title Pregnancy Outcomes of Exposure to Methimazole Study
Date of disclosure of the study information 2015/12/11
Last modified on 2017/12/26

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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
Middle name
Last name NAOKO ARATA
Organization National Center for Child Health and Development, Tokyo, Japan
Division name Maternal Medicine
Zip code
Address 2-10-1 Okura, Setagaya, Tokyo,157-8535, JAPAN
TEL 03-5494-7151
Email arata-n@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name NAOKO ARATA
Organization National Center for Child Health and Development, Tokyo, Japan
Division name Maternal Medicine
Zip code
Address 2-10-1 Okura, Setagaya, Tokyo,157-8535, JAPAN
TEL 03-5494-7151
Homepage URL http://www.ncchd.go.jp/kusuri/news_med/poemstudy.html
Email arata-n@ncchd.go.jp

Sponsor
Institute The Japan Drug Information Institute in Pregnancy
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
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 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
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 No longer recruiting
Date of protocol fixation
2007 Year 12 Month 25 Day
Date of IRB
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
2017 Year 12 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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