Graves'
Conditions
Interventions
None listed
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactNAOKO ARATA
National Center for Child Health and Development, Tokyo, Japan Maternal Medicine
Outcome results
None listed