Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
- Conditions
- Suspected Damage to Fetus From Biologic Agents
- Interventions
- Other: clinical evaluation
- Registration Number
- NCT04197232
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
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.
- Detailed Description
Biologic agents are a group of genetically engineered drugs that target the immune system and have gained a lot of popularity in recent years. They act by interfering with cytokine function or production, inhibiting the "second signal" required for T-cell activation or by depleting B-cells. They are used for the treatment of a wide variety of diseases including Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus (SLE), some types of vasculitis and many more. Many of these pathologies occur in young women during child-bearing years and so it is important for these drugs to not only be safe to use for the patient but also during pregnancy for fetus and child. Many studies are conducted on their safety for the patients but few studies are present on the safety of use during pregnancy. There are even fewer studies that follow up for long term effects on the children outside of the perinatal period.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- children born from mothers treated with biologic agents
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description not exposed clinical evaluation 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.
- Primary Outcome Measures
Name Time Method Safety on fetus of biologic agents used during pregnancy 8 years Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)
Safety on fetus of biologic agents used during pregnancy - adequate growth for GA 8 years Evaluation of normal intrauterine development - birth weight (grams), length (cm), head circumference (cm))
Safety on fetus of biologic agents used during pregnancy - neurological development 8 years Evaluation of developmental milestones (age in months of acquisition of head control, sitting position, crawling and standing position)
Safety on fetus of biologic agents used during pregnancy - fetal development 8 years 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))
Safety on fetus of biologic agents used during pregnancy - perinatal complications 8 years Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)
Safety on fetus of biologic agents used during pregnancy - immunological evaluation 8 years Evaluation of immunological status (complete blood count (absolute counts od WBC, Lymphocytes and Neutrophilis), presence of infection (number #), response to vaccines (presence/absence)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS ospedale san raffaele
🇮🇹Milan, Lombardia, Italy