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Het natuurlijk beloop van inflammatoire darmziekten tijdens de zwangerschap

Prospective follow up of the natural history of pregnancy in IBD women

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28895
Enrollment
270
Registered
2014-04-30
Start date
2014-04-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease Pregnancy Gut microbiome

Interventions

No interventions 4 visits (1 before pregnancy, and 1 in each trimester) to obtain blood samples, fecal samples and questionnaires

Sponsors

Erasmus Universit Medical Centre Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Female - Age 18-43 - Confirmed diagnosis of CD, UC or IBDu, by endoscopy and/or pathology - Pregnancy wish

Exclusion criteria

Exclusion criteria: - Incapacity to understand pre-conceptional counseling, informed consent and/or questionnaire (e.g. language barrier, no interpreter) - Diabetes mellitus - Infection with HIV, HBV or HCV - Substance abuse (chronic hard drug use, alcoholism, shorter than 2 years clean) - Other auto-immune diseases

Design outcomes

Primary

MeasureTime frame
- to analyze the gut microbiome of IBD patients during pregnancy; can the changes during pregnancy in the gut microbiome be linked to disease activity/flares.

Secondary

MeasureTime frame
- to analyze the effect of disease activity on pregnancy outcomes (gestational term, birth weight, congenital abnormalities, mode of delivery) - to identify risk factors for an adverse disease course during pregnancy and adverse pregnancy outcomes - to analyze the effect of different IBD medication use, independent of disease activity, during pregnancy on pregnancy course and outcomes - to obtain data on the health of children born to IBD mothers (infections, allergies, growth) until 1 year and compare to children born to healthy mothers

Contacts

Public ContactA. Lima, de

Erasmus MC

a.delima@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)