Prospective follow up of the natural history of pregnant IBD patients

• Conditions: inflammatory bowel disease

• Registration Number: NL-OMON26221
• Lead Sponsor: Prof Dr MJ Bruno, Head of Gastroenterology and Hepatology Department, Erasmus MC, Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

Female
-Age 18-43
-Confirmed diagnosis of CD, UC or IBDu, by endoscopy and/or pathology
oFor the retrospective part of the study:
?Visited the pre-conception outpatient clinic after IBD diagnosis between January 2008 and December 2013 before pregnancy
?Visited the pre-conception outpatient clinic after IBD diagnosis between January 2008 and December 2013 for the first time during pregnancy
- children of participating women

Exclusion Criteria

-Incapacity to understand pre-conceptional counseling, informed consent and/or questionnaire (e.g. language barrier, no interpreter)
-Diabetes mellitus
-Infection with HIV, HBV or HCV
-Substance abuse (chronic hard drug use, alcoholism, shorter than 2 years clean)
-Other auto-immune diseases

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Gut microbiome changes over the course of pregnancy (before pregnancy, T1, T2 and T3 after delivery and and at least 3 months after delivery) in terms of diversity, taxonomic changes and richness<br>-Gut microbiome changes in children from IBD mothers in terms of diversity, taxonomic changes and richness compared to a historical cohort<br>-Disease activity during pregnancy as measured by clinical activity scores (Harvey Bradshaw Index for CD and Simplified Clinical Colitis Activity Index), laboratory findings and/or endoscopy findings.

Secondary Outcome Measures

Name	Time	Method
Birth outcomes<br>Birth weight<br>Gestational term<br>Congenital abnormalities<br>Mode of delivery<br>APGAR scores at 1 minute and 5 minutes<br>-Child health data:<br>oNumber of infections that required antibiotics<br>oHospital admissions<br>oGrowth<br>oReactions to vaccinations<br>oAllergies