IBDMICI-BirthNCT07377188
Pregnancy and Inflammatory Bowel Disease
An observational study of IBD and Crohn's Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- IBD, Crohn's Disease, Ulcerative Colitis
- How many people
- 945 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients suffering from IBD and with at least one pregnancy.
Who may be able to join
- 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
Who cannot join
- women who has not had pregnancy
- not included in EPIMAD register
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Arthur Foulon, MD, (33)3 22 66 88 20, foulon.arthur@chu-amiens.fr
About this study
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.
- Conditions
- IBD, Crohn's Disease, Ulcerative Colitis, Pregnancy
- Keywords
- IBD, Crohn's disease, Ulcerative colitis, pregnancy
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD and pregnancy | Population-based cohort of patients suffering from IBD and with at least one pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of IBD flare during pregnancy
Measured: 2 years
Secondary outcomes (13)
Number of flare during post-partum period
Measured: 2 years
Number of pregnancy
Measured: 2 years
number of children
Measured: 2 years
Number of Intestinal resection
Intestinal resection due to mici during pregnancy and post-partum
Measured: 2 years
Number of hospitalization
Intestinal resection and hospitalization due to mici during pregnancy and post-partum
Measured: 2 years
Number of miscarriage
Measured: 2 years
Number of ectopic pregnancy
Measured: 2 years
Time before conception
Measured: 2 years
Number of women with exposition to corticosteroid
Exposition to corticosteroid during pregnancy and post-partum
Measured: 2 years
Exposition to biotherapy
Exposition to biotherapy during pregnancy and post-partum
Measured: 2 years
Number and indication of cesarean section
Measured: 2 years
Number of anoperineal lesions after the birth
Measured: 2 years
Wexner score for continence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start18 Sep 2020
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 945 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377188
- Sponsor's protocol ID
- PI2019_843_0059
- Acronym
- MICI-Birth
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07377188
- Acronym / sponsor ID
- MICI-Birth / PI2019_843_0059
- Conditions
- IBD, Crohn's Disease, Ulcerative Colitis, Pregnancy
- Keywords
- IBD, Crohn's disease, Ulcerative colitis, pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 945 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD and pregnancy | – | –Population-based cohort of patients suffering from IBD and with at least one pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering from IBD and with at least one pregnancy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- women who has not had pregnancy
- not included in EPIMAD register
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of IBD flare during pregnancy
Time frame: 2 years
13 secondary outcomes
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
Wexner score for continence
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Crohn's Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur FOULON, Pr (33+3 22 08 73 82, foulon.arthur@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of IBD flare during pregnancy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.