None listed
Conditions
Brief summary
People with inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, often become pregnant during their reproductive years, but active disease during pregnancy can increase the risk of complications for both mother and baby. This observational study will assess standard of care investigations (eg. routine blood tests, intestinal ultrasound, fetal scans) and combine with research blood tests (placental biomarkers) and placental assessment using advanced histological imaging to better understand how immune activity in pregnant people with IBD is linked to changes in the placenta as well as how it can impact complications in the mother and the baby. The study aims to identify blood based biomarkers that may help identify high risk pregnancies early. We hypothesise that higher levels of inflammation in pregnant people with active IBD are associated with changes in placental function and subsequently lead to maternal and fetal complications.
Interventions
Female patients with IBD who fall pregnant will be observed during the pregnancy with standard of care blood tests, stool samples, intestinal ultrasounds as well new research blood biomarkers. Placental studies will be conducted after delivery of the neonate.
Standard of care tests which includes: blood tests, stool samples, intestinal ultrasounds
Research tests: blood/ placental biomarkers and advanced placental histological imaging.
Other than providing an additional blood sample every tri
Female patients with IBD who fall pregnant will be observed during the pregnancy with standard of care blood tests, stool samples, intestinal ultrasounds as well new research blood biomarkers. Placental studies will be conducted after delivery of the neonate. Standard of care tests which includes: blood tests, stool samples, intestinal ultrasounds Research tests: blood/ placental biomarkers and advanced placental histological imaging. Other than providing an additional blood sample every trimester, there are no experimental or additional research procedures for the mother or the fetus during pregnancy. After delivery of baby and placenta, with mother's consent, the research team will conduct laboratory assessment on placental tissue (including but not limited to advanced histological imaging). Placental tissue taken for research will include samples as below (whole placenta is not required and the remaining placenta will be disposed as medical waste which is the routine and standard of care process): Formalin-Fixed, Paraffin-Embedded (FFPE) for histology, Fresh and FFPE (immunofluorescence and multiplexed spatial analysis), Fresh (snap-frozen for protein-based analyses e.g. Western blot, mass spectrometry), Fresh and FFPE (for total tissue RNA-based analyses e.g. RNA seq and spatial transcriptomics) and Fresh (will be used for organoid prep). Data collection from the participant and the fetus (including growth scan parameters) will be every trimester. Placental studies will be conducted after delivery of the neonate. All data will be prospectively collected.
Sponsors
Royal Melbourne Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
IBD Arm Pregnant women with IBD being seen at the IBD clinic at the Royal Melbourne Hospital aged 18-45 with a viable pregnancy at more than 8 weeks gestational age and less than 28 weeks gestational age who are considered to be at low risk for pregnancy complications excluding consideration of their IBD will be included in this study. Medications: Patients can be on IBD conventional or advanced treatments. Patients can be on steroids (all doses and formulation). Patients on aspirin will be included (newly commenced or continuing). Surgeries: Patients with previous IBD related surgeries, i.e., colectomy, ileal resection, pouch, peri anal surgeries (including seton insertion) will be included. *Control Arm Pregnant women with with no known diagnosis of IBD being seen at the low risk antenatal clinic at the Royal Women's Hospital aged 18-45 with a viable pregnancy at more than 8 weeks gestational age and less than 28 weeks gestational age who are considered to be at low risk for pregnancy complications will be included in this study. Medications: Any medications Surgeries: Any previous surgeries
Exclusion criteria
*IBD Arm Patients who do not permit or are unwilling to consent to this study will be excluded. Patients with pregnancy deemed high risk due to other concomitant comorbidities (excepting IBD) will be excluded, e.g.; congestive cardiac failure; ischemic heart disease; chronic obstructive pulmonary disease; active malignancy; active thromboembolism; previous high-risk venous thromboembolism (large burden deep vein thrombosis or pulmonary embolism) and those on anticoagulation (patients on anti-platelets will be included for the study). *Control Arm Patients who do not permit or are unwilling to consent to this study will be excluded. Patients with pregnancy deemed high risk due to other concomitant comorbidities will be excluded, e.g.; congestive cardiac failure; ischemic heart disease; chronic obstructive pulmonary disease; active malignancy; active thromboembolism; previous high-risk venous thromboembolism (large burden deep vein thrombosis or pulmonary embolism) and those on anticoagulation (patients on anti-platelets will be included for the study).
Outcome results
None listed