Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation.
Xia Chen, Pan Li, Mian Liu...
https://pubmed.ncbi.nlm.nih.gov/31900289Actively Recruiting
Age: 18Years +
FEMALE
Healthy Volunteers
ID05445544
A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Led by Zhujiang Hospital · Updated on 2023-02-08
10000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zhujiang Hospital
Lead Sponsor
N
Nanfang Hospital, Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pregnant women to understand how microbiome, proteomics, and serum markers might help predict preeclampsia, a condition that can affect pregnancy. This multicenter, prospective cohort study also aims to explore how these biological markers relate to pregnancy outcomes such as complications during pregnancy, delivery, and the newborn's health. The study is conducted by Zhujiang Hospital and focuses on maternal and infant microecology in China. Pregnant women who come to the hospital before 14 weeks of gestation are invited to participate. After consenting, they will complete a questionnaire and provide samples including urine, serum, saliva, vaginal swabs, and feces at several points during pregnancy: 11-14 weeks, 22-28 weeks, 32-34 weeks, and at delivery. If possible, placenta, cord blood, and amniotic fluid will also be collected at delivery. Women with preeclampsia during pregnancy will be followed up with similar sampling up to two years after their child is born. Participants will be monitored through various laboratory assessments including 16S rRNA gene sequencing for microbiome analysis and advanced techniques like MALDI-TOF peptidomics and mass spectrometry metabonomics. The study will also evaluate patient-specific risk of preeclampsia using clinical measurements such as mean arterial pressure and serum placental growth factor. Follow-up visits after delivery will occur at 6 weeks, 6 months, 1 year, and 2 years to continue monitoring maternal and infant health. The primary outcomes include microbiome, proteomics, and metabonomics data collected over 34 months, with secondary outcomes assessed over 10 months.
CONDITIONS
Brief Title
A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged �3E=18 years
- Pregnant woman
- With a singleton pregnancy
- Volunteer and receive regular antenatal examinations in the research centers
- Volunteer to sign a written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Monitoring
Duration - From enrollment until delivery
Participants are followed during pregnancy with sample collections and assessments at specific gestational ages.
4 visits during pregnancy at gestational weeks 11-14, 22-28, 32-34, and delivery
Long-term Monitoring
Duration - Up to 2 years after delivery
After delivery, participants and their newborns are followed for up to two years with repeated sample collections and assessments.
4 follow-up visits at 6 weeks, 6 months, 1 year, and 2 years after delivery
Trial Site Locations
Total: 2 locations
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Zhujiang hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
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Research Team
S
Sihua Qin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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