IBD Pregnancy Registry
ConditionInflammatory Bowel Disease (IBD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorCorEvitas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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])
Disqualifiers
Exposure to methotrexate during pregnancy
Trial population
Pregnant individuals across the US \& Canada who learn of the study via nationwide advertising campaigns or via their healthcare providers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-exposed group
Other interventionPregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy
Exposed to IBD pharmacotherapy during pregnancy
DrugPregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy
Treatment groups
832 Participants
are divided into 2 treatment groupsGroup A: IBD pharmacotherapy exposed1 intervention
Group B: IBD pharmacotherapy unexposed1 intervention
Trial outcomes
Primary outcomes
1
Major congenital malformation
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.
Time frame
Full pregnancy period (~9 months)Secondary outcomes
1
Minor congenital malformation
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Time frame
Full pregnancy period (~9 months)2
Spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks.
Time frame
<20 gestational weeks3
Pregnancy termination
A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or because of fetal abnormalities.
Time frame
Full pregnancy period (~9 months)4
Preeclampsia
A disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term, and proteinuria. Or, in the absence of proteinuria, it is defined as new-onset hypertension with the new onset of any of the following: * Thrombocytopenia: platelet count \<100,000/mL * Renal insufficiency: serum creatinine concentrations \>1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease * Impaired liver function: elevated blood concentrations of liver transaminases to twice the normal concentration * Pulmonary edema * New-onset headache unresponsive to medication and not accounted for by alternative diagnoses or visual symptoms
Time frame
Full pregnancy period (~9 months) Source ClinicalTrials.gov