Clinical Trial of high-dose IVIG therapy during pregnancy for women with the historyof pregnancy ending in documented neonatal hemochromatosis
- Conditions
- neonatal hemochromatosis
- Registration Number
- JPRN-jRCT2031220624
- Lead Sponsor
- Sasaki Aiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 8
(1)Pregnant women who have delivered a baby diagnosed with neonatal hemochromatosis
(2)Pregnant women between the ages of 16 and 45 at the time of obtaining consent
(3)Pregnant women who are able to visit the hospital regularly throughout the study period
(4)Pregnant women who have obtained written consent to participate in the study
(1)Women with a history of shock or hypersensitivity to the components of the investigational drug
(2)Women who have been diagnosed with IgA deficiency in the past or women who have serum IgA levels of less than 5 mg/dL in clinical tests during the screening period
(3)Women with a history of thromboembolism
(4)Women with a history of either myocardial infarction or cerebral infarction
(5)Women who showed abnormal findings on ST-T waves on electrocardiograms during the screening period and were clinically suspected of ischemic heart disease
(6)Women with impaired heart function
(7)Women with hereditary fructose intolerance
(8)Women with hemolytic or blood loss anemia
(9)Women with immunodeficiency or immunosuppression
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method