Evaluating the safety of biologic medications used during pregnancy for newborns
Study on the Safety for the Newborn of the Use of Biologics During Pregnancy
This study is trying to see if biologic medications used by pregnant women with autoimmune diseases are safe for their newborns and how they affect the children in the long run.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 12 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT04197232 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of biologic agents used by mothers with autoimmune diseases during pregnancy and their effects on newborns. It focuses on both peri-partum and long-term outcomes for children born to these mothers. By monitoring the health of these children, the study seeks to provide crucial data that could support the use of biologics in pregnant women who do not respond to standard treatments for their conditions. The findings could significantly influence treatment protocols for autoimmune diseases in women of childbearing age.
Who should consider this trial
Good fit: Ideal candidates for this study are children born to mothers who have been treated with biologic agents during pregnancy.
Not a fit: Patients who are not born from mothers treated with biologic agents during pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide reassurance regarding the safety of biologic treatments during pregnancy, potentially improving treatment options for mothers with autoimmune diseases.
How similar studies have performed: While there have been studies on the safety of biologics for patients, few have specifically focused on their effects during pregnancy, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children born from mothers treated with biologic agents Exclusion Criteria: \-
Where this trial is running
Milan, Lombardy
- IRCCS ospedale san raffaele — Milan, Lombardy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.