Pregnancy and Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IBD, Crohn's Disease, Ulcerative Colitis, Pregnancy. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Inflammatory Bowel disease, including Crohn's disease and Ulcerative Colitis, are chronic diseases. Diagnosis is most often done in women of childbearing age. IBD can have and increase the risk of intrauterine growth retardation, preterm birth… Conversely, pregnancy can have an impact on IBD activity during pregnancy. Moreover, IBD course can be influence in post-partum. The investigators will explore IBD course on 945 patients from the EPIMAD register. The investigators will cross the data on the IBD with data on pregnancy, postpartum but also breastfeeding. The principal aim of this study is to assess the number of flares during pregnancy.
Primary outcome measures
- number of IBD flare during pregnancy [Time frame: 2 years]
Secondary outcome measures (12)
- Number of flare during post-partum period [Time frame: 2 years]
- Number of pregnancy [Time frame: 2 years]
- number of children [Time frame: 2 years]
- Number of Intestinal resection [Time frame: 2 years]
- Number of hospitalization [Time frame: 2 years]
- Number of miscarriage [Time frame: 2 years]
- Number of ectopic pregnancy [Time frame: 2 years]
- Time before conception [Time frame: 2 years]
- Number of women with exposition to corticosteroid [Time frame: 2 years]
- Exposition to biotherapy [Time frame: 2 years]
- Number and indication of cesarean section [Time frame: 2 years]
- Number of anoperineal lesions after the birth [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- women between 18 and 50 years old
- MICI diagnosed between 1988 and 2018
- included in EPIMAD registry
- living in Somme
- having had at least one pregnancy
Exclusion criteria
- women who has not had pregnancy
- not included in EPIMAD register
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT07377188 · PI2019_843_0059