Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease.
Uma Mahadevan, Millie D Long, Sunanda V Kane...
https://pubmed.ncbi.nlm.nih.gov/33227283Actively Recruiting
Age: 18Years - 45Years
FEMALE
ID00904878
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Led by University of California, San Francisco · Updated on 2025-07-08
1500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
Crohn's and Colitis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on pregnant women diagnosed with Inflammatory Bowel Disease (IBD) who are receiving biologic medicines or immunosuppressants. The study aims to understand how medication use and disease activity affect pregnancy outcomes and child development up to 18 years after birth. It is a multicenter, prospective observational study conducted at the University of California San Francisco and 30 other sites across the United States. The study enrolls pregnant women with IBD who are currently taking biologics or immunosuppressants. There is no randomized treatment as it is observational; instead, researchers monitor participants throughout their pregnancy and after birth. Data collected include medication exposure and disease activity to evaluate their influence on pregnancy and neonatal outcomes. Participants provide information through assessments over several years. The main outcome measured is whether children born to mothers with IBD experience developmental delays compared to children without IBD, using the Ages and Stages Questionnaire at 12, 24, 36, and 48 months. The study also examines rates of adverse pregnancy outcomes related to medication exposure. Monitoring continues to capture health and developmental data for up to 18 years after birth.
CONDITIONS
Brief Title
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy
You will not qualify if you...
- Pregnant female patients younger than 18 years of age
- Confirmed multiple gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to delivery and postpartum period
Participants who are pregnant and have IBD are observed throughout pregnancy and postpartum to assess pregnancy and neonatal outcomes.
Multiple visits during pregnancy and after delivery
Long-term Monitoring
Duration - Up to 48 months after birth
Participants' children are monitored for developmental outcomes up to 48 months of age.
Assessments at 12, 24, 36, and 48 months postpartum
Trial Site Locations
Total: 2 locations
1
Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations
San Francisco, California, United States, 94115
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
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Research Team
J
Jessica Lim
N
Nicole Arima
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development.
Rebecca Matro, Christopher F Martin, Douglas Wolf...
https://pubmed.ncbi.nlm.nih.gov/29857090