- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377188
Pregnancy and Inflammatory Bowel Disease (MICI-Birth)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Arthur FOULON, Pr
- Phone Number: 33+3 22 08 73 82
- Email: foulon.arthur@chu-amiens.fr
Study Locations
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-
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Amiens, France, 80480
- Recruiting
- CHU Amiens
-
Contact:
- Arthur Foulon, MD
- Phone Number: (33)3 22 66 88 20
- Email: foulon.arthur@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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IBD and pregnancy
Population-based cohort of patients suffering from IBD and with at least one pregnancy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of IBD flare during pregnancy
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of flare during post-partum period
Time Frame: 2 years
|
2 years
|
|
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Number of pregnancy
Time Frame: 2 years
|
2 years
|
|
|
number of children
Time Frame: 2 years
|
2 years
|
|
|
Number of Intestinal resection
Time Frame: 2 years
|
Intestinal resection due to mici during pregnancy and post-partum
|
2 years
|
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Number of hospitalization
Time Frame: 2 years
|
Intestinal resection and hospitalization due to mici during pregnancy and post-partum
|
2 years
|
|
Number of miscarriage
Time Frame: 2 years
|
2 years
|
|
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Number of ectopic pregnancy
Time Frame: 2 years
|
2 years
|
|
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Time before conception
Time Frame: 2 years
|
2 years
|
|
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Number of women with exposition to corticosteroid
Time Frame: 2 years
|
Exposition to corticosteroid during pregnancy and post-partum
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2 years
|
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Exposition to biotherapy
Time Frame: 2 years
|
Exposition to biotherapy during pregnancy and post-partum
|
2 years
|
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Number and indication of cesarean section
Time Frame: 2 years
|
2 years
|
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Number of anoperineal lesions after the birth
Time Frame: 2 years
|
2 years
|
|
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Wexner score for continence
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2019_843_0059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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