CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- Major congenital malformation
研究概览
简要总结
Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following:
Research question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy?
The primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy.
The secondary objectives of the registry are:
To estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with IBD who are exposed to IBD pharmacotherapies during pregnancy.
To contextualize the prevalence of outcomes among pregnant individuals who are exposed to IBD pharmacotherapies during pregnancy and estimate the prevalence of all outcomes of interest among pregnant individuals with IBD who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.
If sample size permits, to estimate the risk ratio for each outcome, comparing the outcomes of pregnant individuals with IBD who are exposed to IBD pharmacotherapy with those who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.
Data collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.
详细描述
Rationale and Background:
Inflammatory bowel disease (IBD) is a group of chronic inflammatory conditions that affect the gastrointestinal tract and can be divided into two main types: Crohn's disease (CD) and ulcerative colitis (UC). Half of the people diagnosed with IBD received their diagnosis before the age of 35 years, which coincides with the peak reproductive years for women. Studies have shown that IBD is associated with increased risk of adverse pregnancy and fetal outcomes, including preterm birth, stillbirth, and low birth weight. The CorEvitas IBD Pregnancy Registry (IBD-PR) aims to collect real-world evidence on the safety of IBD pharmacotherapies during pregnancy and the first year of infant life and provide valuable insights into the risks and safety profiles of IBD medications, enabling healthcare professionals to make more informed decisions when managing IBD in pregnant individuals.
Research Question and Objectives: Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following:
The research question is: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to IBD pharmacotherapies during pregnancy?
The primary objective of the registry is to estimate the prevalence of major congenital malformations (MCM) among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Exposed and unexposed cohort:
- •A resident of the US or Canada at enrollment
- •Currently pregnant
- •18 to 50 years of age at enrollment
- •Physician-confirmed diagnosis of IBD (UC, CD, other and unspecified noninfective gastroenteritis and colitis [ICD-10 K52] and indeterminate colitis [ICD-10 K52.3])
- •Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant institutional review board (IRB)/independent ethics committee, verbal consent, indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- •Authorize their HCP to provide data to the registry
- •Provide contact information (for participant and HCPs)
- •Exposed cohort only:
- •Exposed to an IBD pharmacotherapy during pregnancy
排除标准
- •Exposed and unexposed cohort:
- •Exposure to methotrexate during pregnancy
研究组 & 干预措施
IBD pharmacotherapy exposed
Individuals with a diagnosis of IBD who are exposed to an approved IBD pharmacotherapy at any time during pregnancy
干预措施: Exposed to IBD pharmacotherapy during pregnancy (Drug)
IBD pharmacotherapy unexposed
Individuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapy during pregnancy
干预措施: Non-exposed group (Other)
结局指标
主要结局
Major congenital malformation
时间窗: Full pregnancy period (~9 months)
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
次要结局
- Postnatal growth deficiency(Up to 12 months of age)
- Infant death(Up to 12 months of age)
- Pregnancy induced hypertension(>20 gestational weeks)
- Placental abruption(Full pregnancy period (~9 months))
- Infant developmental delay(Up to 12 months of age)
- Infant hospitalization(Up to 12 months of age)
- Infant infections (serious or nonserious)(Up to 12 months of age)
- Minor congenital malformation(Full pregnancy period (~9 months))
- Spontaneous abortion(<20 gestational weeks)
- Pregnancy termination(Full pregnancy period (~9 months))
- Gestational diabetes(Full pregnancy period (~9 months))
- Stillbirth(≥20 gestational weeks)
- Preterm birth(<37 gestational weeks)
- Small for gestational age(At infant birth (up to 12 months of age))
- Preeclampsia(Full pregnancy period (~9 months))
- Eclampsia(Full pregnancy period (~9 months))