Evaluating microbiome and serum markers for preeclampsia screening in pregnant women
A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Zhujiang Hospital · NCT05445544
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Zhujiang Hospital (other) |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT05445544 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with pre-existing serious medical conditions, a history of preeclampsia, or multiple pregnancies may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preeclampsia, Microbiome, preeclampsia