NCT07377188

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
945

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Sep 2020Jul 2026

Study Start

First participant enrolled

September 18, 2020

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

November 17, 2025

Last Update Submit

February 4, 2026

Conditions

IBDCrohn's DiseaseUlcerative ColitisPregnancy

Keywords

IBDCrohn's diseaseUlcerative colitispregnancy

Outcome Measures

Primary Outcomes (1)

  • number of IBD flare during pregnancy

    2 years

Secondary Outcomes (13)

  • Number of flare during post-partum period

    2 years

  • Number of pregnancy

    2 years

  • number of children

    2 years

  • Number of Intestinal resection

    2 years

  • Number of hospitalization

    2 years

  • +8 more secondary outcomes

Study Arms (1)

IBD and pregnancy

Population-based cohort of patients suffering from IBD and with at least one pregnancy.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from IBD and with at least one pregnancy.

You may qualify if:

  • 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

You may not qualify if:

  • women who has not had pregnancy
  • not included in EPIMAD register

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Central Study Contacts

Arthur FOULON, Pr

CONTACT

33+3 22 08 73 82foulon.arthur@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 29, 2026

Study Start

September 18, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)