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van CCT (UK)

van CCT (UK)

Het natuurlijk beloop van inflammatoire darmziekten tijdens de zwangerschap

- candidate number17616
- NTR NumberNTR4550
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-apr-2014
- Secondary IDsMEC-2013-579 NL 47357.078.13
- Public TitleHet natuurlijk beloop van inflammatoire darmziekten tijdens de zwangerschap
- Scientific TitleProspective follow up of the natural history of pregnancy in IBD women
- hypothesisThe gut microbiome changes profoundly during pregnancy in healthy women. We hypothesize these microbiome changes will also occur in pregnant IBD women and can possibly have clinical implications.
- Healt Condition(s) or Problem(s) studiedIBD, Inflammatory bowel disease, Pregnancy, Gut microbiota
- Inclusion criteria- Female
- Age 18-43
- Confirmed diagnosis of CD, UC or IBDu, by endoscopy and/or pathology
- Pregnancy wish
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 28-apr-2014
- planned closingdate30-apr-2019
- Target number of participants270
- InterventionsNo interventions
4 visits (1 before pregnancy, and 1 in each trimester) to obtain blood samples, fecal samples and questionnaires
- Primary outcome- 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 outcome- 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
- TimepointsVisit 1: before pregnancy (when patient expresses a pregnancy wish)
Visit 2: First trimester (gestational week 10)
Visit 3: Second trimester (gestational week 20)
Visit 4: Third trimester (gestational week 30)
1 year after delivery: retrospectively obtain health data on th child via General Practitioner
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryCrohn’s disease and ulcerative colitis, collectively referred to as inflammatory bowel disease (IBD), are chronic, relapsing diseases. The exact etiology remains unknown, however, it is currently believed to be a complex interaction between genetic susceptibility, gut microbiota, the host immune response and environmental factors(1). IBD typically arises at a young, fertile age, as 50% of patients will be younger than 35 years old when the diagnosis is established(2). Therefore, reproductive issues are of important concern for both the IBD patients and their treating physicians. Preconception counseling in these patients remains challenging, as many complex questions can only be answered with limited, mainly retrospective and sometimes conflicting data. In addition, most of the (registry based) cohorts are outdated(3-10), not including the most recent therapies for IBD like anti-TNF, which have become a mainstay in IBD treatment over the last decade(11). Obviously, the need for an up-to-date, properly conducted, prospective cohort is long overdue. We therefore propose to conduct a prospective cohort study in IBD females with a pregnancy wish and pregnant IBD females, to gather data on IBD characteristics during pregnancy and the effect of pregnancy on IBD. Furthermore, as a recent study has shown pregnancy to influence gut microbiota in non IBD patients(12), we also propose to investigate whether the gut microbiome in IBD patients changes during pregnancy and whether these changes have any clinical implications.
- Main changes (audit trail)
- RECORD30-apr-2014 - 26-mei-2014

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