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.
Inflammatory Bowel Disease (IBD)
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.
IBD Pregnancy Registry
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PPD, Wilmington, North Carolina, United States, 28401
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 50 Years
FEMALE
No
CorEvitas,
Ronna L Chan, PhD, MPH, PRINCIPAL_INVESTIGATOR, PPD, Part of Thermo Fisher Scientific
2032-09