Inflammatory Bowel Disease (IBD)IBD-PRNCT06910553
IBD Pregnancy Registry
An observational study of Inflammatory Bowel Disease (IBD), run by CorEvitas at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Non-exposed group and Exposed to IBD pharmacotherapy during pregnancy
- How many people
- 832 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant individuals across the US \& Canada who learn of the study via nationwide advertising campaigns or via their healthcare providers
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Exposed and unexposed cohort:
- Exposure to methotrexate during pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PPD
Wilmington, North Carolina, 28401
CorEvitas Clinical Research Associate, 1-800-616-3791, ibd-pr@corevitas.com
About this study
Official title: CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
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?
Read more
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Non-exposed group, Exposed to IBD pharmacotherapy during pregnancy
- Keywords
- Pregnant, IBD, Registry, UC, Inflammatory Bowel Disease, Ulcerative Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-exposed groupOther
Pregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy
Exposed to IBD pharmacotherapy during pregnancyDrug
Pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| IBD pharmacotherapy exposed | Individuals with a diagnosis of IBD who are exposed to an approved IBD pharmacotherapy at any time during pregnancy Receives: Drug: Exposed to IBD pharmacotherapy during pregnancy | |
| IBD pharmacotherapy unexposed | Individuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapy during pregnancy Receives: Other: Non-exposed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Full pregnancy period (~9 months)
Secondary outcomes (16)
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.
Measured: Full pregnancy period (~9 months)
Spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.
Measured: <20 gestational weeks
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.
Measured: Full pregnancy period (~9 months)
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
Measured: Full pregnancy period (~9 months)
Eclampsia
New-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use.
Measured: Full pregnancy period (~9 months)
Stillbirth
Involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350g
Measured: ≥20 gestational weeks
Preterm birth
A live birth occurring at <37 gestational weeks
Measured: <37 gestational weeks
Small for gestational age
Birth weight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.
Measured: At infant birth (up to 12 months of age)
Gestational diabetes
Any degree of glucose intolerance with onset or first recognition during pregnancy
Measured: Full pregnancy period (~9 months)
Pregnancy induced hypertension
A disorder of pregnancy defined as a systolic blood pressure of 140 mm Hg or more or a diastolic blood pressure of 90 mm Hg or more, or both, on two occasions at least 4 hours apart after 20 weeks of gestation in a woman with previously normal blood pressure
Measured: >20 gestational weeks
Placental abruption
Premature separation of the placenta from its uterine attachment before the delivery of a fetus
Measured: Full pregnancy period (~9 months)
Postnatal growth deficiency
Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts
Measured: Up to 12 months of age
Infant developmental delay
Failure to achieve the developmental milestones for chronological age, as defined by the CDC.
Measured: Up to 12 months of age
Infant hospitalization
The admission of an infant to a hospital
Measured: Up to 12 months of age
Infant infections (serious or nonserious)
Infant infections that resulted in medical visit or hospitalization
Measured: Up to 12 months of age
Infant death
The death of an infant before his or her first birthday
Measured: Up to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ronna L Chan, PhD, MPH, Principal investigator, PPD, Part of Thermo Fisher Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910553
- Sponsor's protocol ID
- IBDPR-310
- Acronym
- IBD-PR
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
- ClinicalTrials.gov ID
- NCT06910553
- Acronym / sponsor ID
- IBD-PR / IBDPR-310
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Pregnant, IBD, Registry, UC, Inflammatory Bowel Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 832 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD pharmacotherapy exposed | – | Drug: Exposed to IBD pharmacotherapy during pregnancyIndividuals with a diagnosis of IBD who are exposed to an approved IBD pharmacotherapy at any time during pregnancy |
| IBD pharmacotherapy unexposed | – | Other: Non-exposed groupIndividuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapy during pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant individuals across the US \& Canada who learn of the study via nationwide advertising campaigns or via their healthcare providers
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Exposure to methotrexate during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-exposed groupPregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy | Other | IBD pharmacotherapy unexposed |
| Exposed to IBD pharmacotherapy during pregnancyPregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy | Drug | IBD pharmacotherapy exposed |
Primary outcome
Major congenital malformation
Time frame: 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.
16 secondary outcomes
Minor congenital malformation
Time frame: Full pregnancy period (~9 months)
Spontaneous abortion
Time frame: <20 gestational weeks
Pregnancy termination
Time frame: Full pregnancy period (~9 months)
Preeclampsia
Time frame: Full pregnancy period (~9 months)
Eclampsia
Time frame: Full pregnancy period (~9 months)
Stillbirth
Time frame: ≥20 gestational weeks
Preterm birth
Time frame: <37 gestational weeks
Small for gestational age
Time frame: At infant birth (up to 12 months of age)
Gestational diabetes
Time frame: Full pregnancy period (~9 months)
Pregnancy induced hypertension
Time frame: >20 gestational weeks
Placental abruption
Time frame: Full pregnancy period (~9 months)
Postnatal growth deficiency
Time frame: Up to 12 months of age
Infant developmental delay
Time frame: Up to 12 months of age
Infant hospitalization
Time frame: Up to 12 months of age
Infant infections (serious or nonserious)
Time frame: Up to 12 months of age
Infant death
Time frame: Up to 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronna L Chan, PhD, MPH principal investigator
PPD, Part of Thermo Fisher Scientific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronna L Chan, PhD, MPH (800-616-3791, ibd-pr@corevitas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major congenital malformation (time frame: Full pregnancy period (~9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.