Clinical Trials in China / NCT05445544
Recruiting
Observational
A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
NCT05445544 · tracked via the Priya Life Science China tracker
Condition(s) studied
PreeclampsiaMicrobiome
Investigational drug(s) / intervention(s)
Observational studies, The diagnosis was preeclampsia
Observational studies, The diagnosis was preeclampsia: Observational studies, The diagnosis was preeclampsia
Study summary
major objective This multicenter, prospective cohort study aims at evaluating the predictive value of microbiome ,proteomics and serum markers in preeclampsia. secondary objective to evaluate the value of microbiome,proteomics and serum markers in assessing pregnancy outcome (complications during pregnancy and delivery, delivery) and neonatal prognosis.
Eligibility
Inclusion Criteria:
* Aged \>=18 years;
* Pregnancy woman;
* With a singleton pregnancy;
* Volunteer and receive regular antenatal examinations in the research centers;
* Volunteer to sign a written informed consent.
Exclusion Criteria:
* Concurrent with hypertension, diabetes, liver and kidney diseases, hematonosis and other serious diseases of pre-pregnancy women, including patients requiring long-term medication for primary diseases;
* With history of preeclampsia;
* Tumor patients concurrent with serious infection requiring long-term drug treatment;
* Pregnant women conceiving through in vitro fertilization;
* Multiple pregnancies;
* Patients with clear indications of medical pregnancy termination during early pregnancy;
* Any medical or non-medical conditions deemed inappropriate for study participation according to the investigator.
Primary outcome measure(s)
- microbiome — 34 months
To evaluate the predictive value of microbiome in preeclampsia. To observe the changes of microbiome in pregnant women with preeclampsia from 11-14 weeks of gestation to two years postpartum.The microbial composition of the stool samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. - proteomics — 34 months
To evaluate the predictive value of proteomics in preeclampsia. To observe the changes of urine and serum proteomics in pregnant women with preeclampsia from 11-14 weeks of gestation to two years postpartum. proteomics is the large-scale study of small or big molecules, such as protein,polypeptide. - metabonomics — 34 months
To evaluate the predictive value of metabonomics in preeclampsia. To observe the changes of serum metabonomics in pregnant women with preeclampsia from 11-14 weeks of gestation to two years postpartum. Metabolomics is the large-scale study of small molecules, such as fatty acids, bile acids, lipid mediators and others.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | Recruiting |
| Zhujiang hospital | Guangzhou | Guangdong | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05445544 on ClinicalTrials.gov ↗ ← All trials in China