Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
Recruiting
Observational Study
Suspected Damage to Fetus From Biologic Agents
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 1 Day – 12
- Sex
- Any
- Study type
- Observational
- Participants needed
- 50 (estimated)
- Sponsor
- IRCCS San Raffaele · Other
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About This Trial
The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women af…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* children born from mothers treated with biologic agents
Exclusion Criteria:
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Contacts
No contact information available.