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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03785093
Eligibility Criteria:
Inclusion Criteria:
1. Expectant ethnic Chinese mothers aged 18 - 45 years who are in the first trimester of pregnancy
2. Singleton pregnancy
3. Plan to give birth in the Prince of Wales Hospital, Hong Kong and stay with the child in Hong Kong for the next 3 years
4. Willing to provide serial biological samples for microbiota detection
5. Willing for her coming newborn to be prospectively followed up for clinical and microbiota data collection in PWH
6. Participate voluntarily and capable of giving informed consent
Exclusion Criteria:
1. Significant medical conditions especially those required long term medications, such as oral steroid, antihypertensive drugs, diabetic medications and lipid-lowering agents, during or before pregnancy
2. History of chronic inflammatory or neoplastic diseases involving the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer)
3. Significant pregnancy complications, such as intrauterine foetal demise/stillbirth, extreme prematurity, or pre-labour rupture of membranes before 24 weeks
4. Mother with mental incapacity such that they are not able to give informed consent
5. Foetal chromosomal or clinically significant structural abnormalities
6. The current pregnancy is a conception through either sperm or ovum donation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03785093
Study Brief:
Protocol Section:
NCT03785093