NCT04197232|UnknownDMC
Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
BIOGN1
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BIOGN1
Sponsor study identifier
observational
50
1 country
1
Study Start
August 31, 2018
Actual (reported)Primary Completion
August 31, 2018
Actual (reported)Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 affected by autoimmune diseases unresponsive to standard treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2018
Actual (reported)August 31, 2018
Actual (reported)November 27, 2019
Actual (reported)December 13, 2019
Actual (reported)August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety on fetus of biologic agents used during pregnancy
Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)
8 years
Safety on fetus of biologic agents used during pregnancy - fetal development
Evaluation of normal intrauterine development (measured by presence of Intra-Uterine Growth Restriction, presence of malformations (number#), birth weight (grams), length (cm), head circumference (cm))
8 years
Safety on fetus of biologic agents used during pregnancy - adequate growth for GA
Evaluation of normal intrauterine development - birth weight (grams), length (cm), head circumference (cm))
8 years
Safety on fetus of biologic agents used during pregnancy - perinatal complications
Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)
8 years
Safety on fetus of biologic agents used during pregnancy - neurological development
Evaluation of developmental milestones (age in months of acquisition of head control, sitting position, crawling and standing position)
The modality of study is a cohort study that evaluates the performance of children exposed to biologic agents during pregnancy compared to the performance of children born at the same gestational age not exposed to biologic agents.
The modality of study is a cohort study that evaluates the performance of children exposed to biologic agents during pregnancy compared to the performance of children born at the same gestational age not exposed to biologic agents.
\- In children: general clinical evaluation, birth weight, APGAR, ECG, admission to ICU, hospital admissions in perinatal age, presence of malformations; complete blood count, inflammatory index, complement, antibiotic treatment, brain ultra-sound, presence of infection, presence of sepsis, presence of necrotizing enterocolitis, growth curve, presence of recurrent infections, developmental milestones, response to vaccines, admission to hospital in the first year of life.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
children born from mothers treated with biologic agents during pregnancy
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IRCCS ospedale san raffaele
Milan, Lombardy, 20132, Italy
First Submitted
November 27, 2019
First Posted
December 13, 2019
Study Start
August 31, 2018
Actual (reported)Primary Completion
August 31, 2018
Actual (reported)Molar-Incisor Hypomineralization Vs Periodontal Health
8 years
Safety on fetus of biologic agents used during pregnancy - immunological evaluation
Evaluation of immunological status (complete blood count (absolute counts od WBC, Lymphocytes and Neutrophilis), presence of infection (number #), response to vaccines (presence/absence)
8 years
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 13, 2019
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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