UMIN-CTR Clinical Trial

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

Graves' disease

Classification by specialty

Endocrinology and Metabolism	Obstetrics and Gynecology	Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Organization

National Center for Child Health and Development, Tokyo, Japan
MHLW(Japan)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

妊娠と薬情報センター（東京都）

Date of disclosure of the study information

2015

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

Registered date

2015

Year

12

Month

11

Day

Last modified on

2021

Year

06

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023293