Clinical trial NCT06910553: IBD Pregnancy Registry
Official title: CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: Pregnant
IBD
Registry
UC
Inflammatory Bowel Disease
Ulcerative Colitis
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2025-04-04
Enrollment: 832
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant individuals across the US \& Canada who learn of the study via nationwide advertising campaigns or via their healthcare providers

Brief summary: 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.

Detailed description: 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.

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 an IBD pharmacotherapy 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 an IBD pharmacotherapy 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 an IBD pharmacotherapy with outcomes of those who are not exposed to an IBD pharmacotherapy

Data collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.

Study Design: This prospective, observational cohort study is designed to estimate the prevalence of maternal, fetal, and infant outcomes among individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy. For this registry, the index date will be the date of first exposure to the IBD pharmacotherapy for the exposed cohort and the date of enrollment for the unexposed cohort. The risks of pregnancy-related outcomes, maternal outcomes, and neonatal/infant outcomes will be estimated for participants with IBD exposed and unexposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.

Population: The registry population will include two cohorts of pregnant individuals: one cohort of individuals with a diagnosis of IBD who are exposed to an IBD pharmacotherapy during pregnancy and one cohort of individuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapies during pregnancy.

Variables: Individuals will be considered exposed during pregnancy if at least one dose of an IBD treatment is taken during pregnancy or up to at least five times the product's half-life before conception. The primary outcome of interest is MCMs. The maternal and pregnancy secondary outcomes include minor congenital malformations, preeclampsia, eclampsia, spontaneous abortion, stillbirth, pregnancy termination, preterm birth, small for gestational age, gestational diabetes, pregnancy-induced hypertension, and placental abruption. The infant secondary outcomes during the first year of life include postnatal growth deficiency, infant developmental delay, infant hospitalization, infant infections (both serious and nonserious), and infant death. Covariates will include demographics, risk factors for the outcomes, comorbidities, concomitant medications, and predictors of treatment with an approved IBD pharmacotherapy.

Data Source: This registry will collect data from participants and healthcare providers involved in their care or the care of their infants via concise data collection forms at predefined timepoints during pregnancy, at pregnancy outcome, and up to 1 year of infant age.

Study Size: The registry aims to include as many pregnant individuals as possible, with no defined upper limit on enrollment in each cohort, to estimate the prevalence of the primary outcome, MCM, with meaningful confidence and precision. This approach aims to achieve adequate sample size to address additional research questions of interest, and/or maintain generalizability and representativeness of the registry population. Assuming a prevalence of MCM equivalent to 3% in each cohort, 1,143 and 303 live births in the analysis population of each cohort are needed to estimate the prevalence of MCM with ±1% and 2% precision, respectively.

Data Analysis: Participant characteristics will be summarized with descriptive statistics for each cohort. Comparative analyses will be conducted for each outcome if sample size permits. Supplementary analyses will be conducted that include pregnant individuals who were excluded from the analysis population. If sample size permits, subgroup and sensitivity analyses will be performed to examine the extent to which changes in certain methods or assumptions affect the results.

Milestones: The IBD-PR is expected to launch in March 2025, and the end of data collection is planned for 30 September 2032.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Exposed and unexposed cohort:

* Exposure to methotrexate during pregnancy

Primary outcomes:
measure: Major congenital malformation
timeFrame: Full pregnancy period (~9 months)
Secondary outcomes:
measure: Minor congenital malformation
timeFrame: Full pregnancy period (~9 months)
measure: Spontaneous abortion
timeFrame: <20 gestational weeks
measure: Pregnancy termination
timeFrame: Full pregnancy period (~9 months)
measure: Preeclampsia
timeFrame: Full pregnancy period (~9 months)
measure: Eclampsia
timeFrame: Full pregnancy period (~9 months)
measure: Stillbirth
timeFrame: ≥20 gestational weeks
measure: Preterm birth
timeFrame: <37 gestational weeks
measure: Small for gestational age
timeFrame: At infant birth (up to 12 months of age)
measure: Gestational diabetes
timeFrame: Full pregnancy period (~9 months)
measure: Pregnancy induced hypertension
timeFrame: >20 gestational weeks
measure: Placental abruption
timeFrame: Full pregnancy period (~9 months)
measure: Postnatal growth deficiency
timeFrame: Up to 12 months of age
measure: Infant developmental delay
timeFrame: Up to 12 months of age
measure: Infant hospitalization
timeFrame: Up to 12 months of age
measure: Infant infections (serious or nonserious)
timeFrame: Up to 12 months of age
measure: Infant death
timeFrame: Up to 12 months of age
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD
state: North Carolina
Study officials:
affiliation: PPD, Part of Thermo Fisher Scientific
name: Ronna L Chan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: