Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,750
- 试验地点
- 73
- 主要终点
- To calculate the incide rate of serious infections for the offspring (at eh age of 4 years) based on the medications used to treat IBD.
研究概览
简要总结
This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.
In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.
详细描述
OBJECTIVES Main objective - To assess the safety of drugs used for IBD treatment both for pregnancy and for the offspring mainly focused on the risk of serious infections (from birth and in the first 4 years of life).
Specific objectives
- To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with drugs used for the treatment of IBD.
- To asses the developmental status of children born from IBD mothers during the first 4 years.
- To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
- To compare the prevalence of malformations in children exposed to drugs to treat IBD in utero with the prevalence in children who were not exposed.
- To evaluate the relative risk of developing neoplasm in children exposed to drugs to treat IBD.
Inclusion criteria
- Patients over 18 years of age diagnosed with IBD.
- Confirmed pregnancy.
- Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age diagnosed with IBD.
- •Confirmed pregnancy.
- •Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).
排除标准
- •Patients who do not accept to participate in the study.
结局指标
主要结局
To calculate the incide rate of serious infections for the offspring (at eh age of 4 years) based on the medications used to treat IBD.
时间窗: 4 years
To assess the prevalence of complications related to drugs used for IBD treatment for the offspring.
To calculate the incide rate of serious adverse events during pregnancy (evaluated at the end of pregnancy) based on the medications used to treat IBD.
时间窗: 9 months
To asses the prevalence of complications related to drugs used for IBD treatment for pregnancy.
To calculate the incide rate of serious infections during pregnancy (evaluated and the end of pregnancy) based on the medications used to treat IBD.
时间窗: 9 months
To assess the prevalence of complications related to drugs used for IBD treatment for pregnancy.
To calculate the incide rate of serious adverse events during offspring (at the age of 4 years) based on the medications used to treat IBD.
时间窗: 4 years
To asses the prevalence of complications related to drugs used for IBD treatment for offspring mainly focused on the risck of serious infections at the age of 4 years.
次要结局
- 4. To calculate the Hazard ratio of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.(4 years and 9 months)
- 6. To calculate the Hazard ratio of developing neoplasm in children exposed to drugs to treat IBD.(4 years and 9 months)
- 2. To calculate the Odds ratio of serious adverse events (including abortions) during pregnancy and delivery based on the drugs used for the treatment of IBD.(4 years and 9 months)
- 3. To measure the developmental status of children born from IBD mothers with the ASQ-3 questionnaire during the first 4 years.(4 years and 9 months)
- 5. To calculate the proportion of children with malformations and to compare the proportions between exposure groups (children exposed to biologics with those non exposed to these drugs).(4 years and 9 months)