Evaluating microbiome and serum markers for preeclampsia screening in pregnant women
Official title: A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Run by Zhujiang Hospital · NCT05445544 · Data updated 2026-11-12
This study is testing if certain biological markers in pregnant women can help predict preeclampsia early on to improve health outcomes for mothers and babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Status | Recruiting |
| Started | October 19, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 8, 2023 |
| Trial ID | NCT05445544 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 and older with a singleton pregnancy who are willing to participate and provide informed consent.
✕Probably not a fit
Patients with pre-existing serious medical conditions, a history of preeclampsia, or multiple pregnancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective cohort study aims to assess the predictive value of microbiome, proteomics, and serum markers in identifying preeclampsia among pregnant women in China. Participants will be recruited before 14 weeks of gestation and will provide various biological samples at multiple points during their pregnancy and up to two years postpartum. The study will analyze these samples using advanced techniques such as 16S rRNA gene sequencing and mass spectrometry to evaluate the relationship between these biological markers and pregnancy outcomes. The goal is to improve screening methods for preeclampsia and enhance maternal and neonatal health.
Why it matters
Potential benefit: If successful, this study could lead to improved screening methods for preeclampsia, potentially reducing complications for mothers and infants.
How similar studies have gone: While the approach of using microbiome and proteomics for preeclampsia screening is innovative, similar studies have shown promise in related areas, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China Recruiting -
Zhujiang hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Sihua Qin
- Email: 274896180@qq.com
- Phone: 15622136950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.