Study on the Safety for the Newborn of the Use of Biologics During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety on fetus of biologic agents used during pregnancy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children born from mothers treated with biologic agents
排除标准
- 未提供
结局指标
主要结局
Safety on fetus of biologic agents used during pregnancy
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 - immunological evaluation
时间窗: 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)
Safety on fetus of biologic agents used during pregnancy - perinatal complications
时间窗: 8 years
Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)
次要结局
未报告次要终点
研究者
Rosanna Rovelli
Principal Investigator
IRCCS San Raffaele