- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03785093
Intestinal Microbiota on Allergy, Growth and Development (SMARTGenHK)
Intestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong
Study Overview
Status
Conditions
Detailed Description
Our unit is one of the centres contributing to the International multicentre HAPO study. We recruited 1760 Chinese pregnant women between 2000 and 2005. The HAPO study investigated whether any adverse outcome was associated with mild degree of GDM. All mothers underwent a 75-gram OGTT at 24-32 weeks gestation, but clinicians were blinded to the results as long as the fasting PG was ≤ 5.8 mmol/L & 2-hour PG ≤ 11.1 mmol/L. The maternal serum C-peptide and HbA1c, cord serum C-peptide and early neonatal PG, pregnancy outcome and the neonatal anthropometric parameters are available for future study. This is so far the largest cohort in a Chinese population who has been investigated for glycaemia during pregnancy, but with OGTT results remained undisclosed to subjects and clinicians. This unique cohort can allow us to study the effect of in-utero hyperglycemia on the cardiometabolic risks at childhood, adolescence and adulthood.
Eligible subjects are all mother-child pairs participating in the original HAPO study. Children born preterm before 37 weeks of gestation, non-Chinese and whose mother's OGTT result were unblinded during pregnancy will be excluded.The family (the child and the mother) will be invited for a third follow-up assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, China
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Hong Kong, Hong Kong, China, Hong Kong, Shatin
- Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Expectant ethnic Chinese mothers aged 18 - 45 years who are in the first trimester of pregnancy
- Singleton pregnancy
- 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
- Willing to provide serial biological samples for microbiota detection
- Willing for her coming newborn to be prospectively followed up for clinical and microbiota data collection in PWH
- Participate voluntarily and capable of giving informed consent
Exclusion Criteria:
- 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
- History of chronic inflammatory or neoplastic diseases involving the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer)
- Significant pregnancy complications, such as intrauterine foetal demise/stillbirth, extreme prematurity, or pre-labour rupture of membranes before 24 weeks
- Mother with mental incapacity such that they are not able to give informed consent
- Foetal chromosomal or clinically significant structural abnormalities
- The current pregnancy is a conception through either sperm or ovum donation
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Chinese Family
Chinese parents and their offsprings
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite allergy disease
Time Frame: 3 years of age
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wheezing, asthma, skin atopy, food allergy
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3 years of age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ting Fan Leung, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Smart-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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