Registry for pregnant individuals with Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry collects data on pregnant individuals diagnosed with Inflammatory Bowel Disease (IBD) to assess the safety of IBD pharmacotherapies during pregnancy. It aims to estimate the prevalence of major congenital malformations and other maternal, fetal, and infant outcomes among those exposed to IBD treatments compared to those who are not. The registry will provide real-world evidence to help healthcare professionals make informed decisions regarding the management of IBD in pregnant patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Ppd
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ronna L Chan, PhD, MPH — PPD, Part of Thermo Fisher Scientific
• Study coordinator: Ronna L Chan, PhD, MPH
• Email: ibd-pr@corevitas.com
• Phone: 800-616-3791

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DISC-0974-201 for adults with IBD-related anemia

  This Phase 2 trial will test whether DISC-0974-201 helps adults with inflammatory bowel disease who have anemia driven by inflammation.

  Recruiting at 15 sites Phase 2 Disc Medicine, Inc · Birmingham, Alabama and 14 other locations · NCT07368972

• Moderate breathing and movement: Can regular exercise help people with quiescent inflammatory bowel disease feel better?

  This trial tests whether a moderate-intensity exercise program improves quality of life for adults with Crohn's disease or ulcerative colitis who are currently in clinical remission.

  Recruiting Mahidol University · Bangkok Noi, Bangkok · NCT07775794

• Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis in Remission

  This study tests whether a Mediterranean diet, with or without an 8-hour eating window, helps gut health and quality of life in adults with ulcerative colitis in remission.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT07752446

• Screening for lipid disorders in children and teens with chronic diseases to flag cardiovascular risk

  This study tests a blood test and a questionnaire to screen children and teens with chronic conditions for lipid metabolism disorders and familial hyperlipidemia.

  Recruiting Jena University Hospital · Jena · NCT07716488

• Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease

  This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.

  Recruiting at 2 sites Maastricht University Medical Center · 's-Hertogenbosch and 2 other locations · NCT07647640

• PVT401 in healthy adults

  This trial will test intravenous PVT401 in healthy adults who carry the HLA DRB4*0101 or DRB4*0103 allele to see how the drug behaves in the body and whether single and multiple doses are safe.

  Recruiting Phase 1 Parvus Therapeutics, Inc. · Melbourne, Victoria · NCT07423000

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.