Pregnancy and Inflammatory Bowel Disease | NCT07377188

Studies
Pregnancy and Inflammatory Bowel Disease

NCT07377188

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Recruiting

Last Update Posted

Feb 5, 2026Actual

Enrollment

945Estimated

Phase

Not provided

Conditions

IBD
Crohn's Disease
Ulcerative Colitis
Pregnancy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2020Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Jan 22, 2026

First Posted Date

Jan 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

945Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBD and pregnancy		Population-based cohort of patients suffering from IBD and with at least one pregnancy.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of IBD flare during pregnancy		2 years

Secondary Outcomes

Measure	Description	Time Frame
Number of flare during post-partum period		2 years
Number of pregnancy		2 years
number of children

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients suffering from IBD and with at least one pregnancy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arthur FOULON, Pr	Contact	33+3 22 08 73 82		foulon.arthur@chu-amiens.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens	Recruiting	Amiens		80480	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided