Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT03116568
Eligibility Criteria:
1. Pregnant Women with IBD (Case) Inclusion Criteria 1. Be pregnant or planning pregnancy 2. To have confirmed IBD 3. To plan giving birth in Hong Kong Exclusion Criteria 1. Pregnancy complications, such as intrauterine fetal demise/stillbirth, preeclampsia, hyperemesis gravidarum, active infection, including chorioamnionitis or sepsis 2. Fetus chromosomal or structural abnormalities 3. Known history of HIV 4. History of Colectomy or ileo-anal pouch
2. Pregnant Women without IBD (Control) Inclusion Criteria 1. To be pregnant or planning pregnancy 2. Subjects without IBD 3. To plan giving birth in Hong Kong Exclusion Criteria 1. Pregnancy complications, such as intrauterine fetal demise/stillbirth, preeclampsia, hyperemesis gravidarum, active infection, including chorioamnionitis or sepsis 2. Fetus chromosomal or structural abnormalities 3. Known history of HIV 4. History of colectomy or ileo-anal pouch 5. Autoimmune diseases 6. Blood in stools 7. History of perianal fistula or abscesses
3. Family Members Inclusion Criteria 1. Residing in the same household with the pregnant woman from both case and control groups e.g. child, spouse, parents of the pregnant woman 2. The subject or, when applicable, the subject's legally acceptable representative (or parent or legal guardians) signs and dates a written, informed consent form prior to the initiation of study.
4. New Born Baby Inclusion Criteria 1. Be a new born baby of enrolled pregnant women from both case and control groups 2. The subject's parents or legally guardians sign and date a written, informed consent form prior to the initiation of study.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
100 Years
Study:
NCT03116568
Study Brief:
Protocol Section:
NCT03116568