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NCT Number: NCT04197232

Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases

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.

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Key information

Conditions

Suspected Damage to Fetus From Biologic Agents

Age range

1 day–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children born from mothers treated with biologic agents

Exclusion criteria

-

Treatment and study plan

Clinical evaluation

Other
  • 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.

Primary outcomes

  1. Safety on fetus of biologic agents used during pregnancy

    Time frame: 8 years

    Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)

  2. Safety on fetus of biologic agents used during pregnancy - fetal development

    Time frame: 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))

  3. Safety on fetus of biologic agents used during pregnancy - adequate growth for GA

    Time frame: 8 years

    Evaluation of normal intrauterine development - birth weight (grams), length (cm), head circumference (cm))

  4. Safety on fetus of biologic agents used during pregnancy - perinatal complications

    Time frame: 8 years

    Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)

  5. Safety on fetus of biologic agents used during pregnancy - neurological development

    Time frame: 8 years

    Evaluation of developmental milestones (age in months of acquisition of head control, sitting position, crawling and standing position)

  6. Safety on fetus of biologic agents used during pregnancy - immunological evaluation

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Study on the Safety for the Newborn of the Use of Biologics During Pregnancy

Acronym: BIOGN1

Important dates

Study start
2018
Primary completion
2018
Study completion
2026
First posted
Dec 13, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.