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Prospective follow up of the natural history of Inflammatory Bowel Disease during pregnancy

Recruiting
Conditions
Crohn's Disease
ulcerative colitis
10017943
10026908
Registration Number
NL-OMON50661
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
270
Inclusion Criteria

female
age 18-43
pregnancy (wish)
confirmed diagnosis of crohn's disease, ulcerative colitis, or IBDU
(endooscopic/histopathologic)

Exclusion Criteria

incapacity to understand informed consent
Infection with HIV, HBV or HCV
Diabetes mellitus
Substance abuse (hard drug use or alcoholism, less than 2 years clean)
other auto immune disease

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Gut microbiome before pregnancy, in the first, second and third trimester,<br /><br>and at least three months after delivery<br /><br>- Gut microbiome changes in children from IBD mothers in terms of diversity,<br /><br>taxonomic changes and richness compared to a historical cohort<br /><br>- Clinical activity scores (Harvey Bradshaw Index for CD and Simplified<br /><br>Clinical Colitis Activity Index for UC)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Gestational term (weeks)<br /><br>- Birth weight (grams)<br /><br>- Small for gestational age (=birth weight < 10th percentile for that<br /><br>gestational term) (yes/no)<br /><br>- Congenital abnormalities<br /><br>- Mode of delivery (vaginal or caesarean section)<br /><br>- Child health data<br /><br>o Number of infections that required antibiotics<br /><br>o Hospital admissions<br /><br>o Growth<br /><br>o Reactions to vaccinations<br /><br>o Allergies</p><br>
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