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Recruiting NCT05445544

A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China

— Observational Preeclampsia Microbiome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational studies, The diagnosis was preeclampsia.
Who it may be relevant to
Registry conditions: Preeclampsia, Microbiome. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

The volunteers will be recruited from the gestational women who come to the hospital before 14 weeks of gestation. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. Then,urines ,serums and salivas as well as vaginal swabs and feces will be taken from each volunteer at gestational ages 11-14, 22-28, 32-34 weeks and delivery period .In delivery period,we will take placentas, cord bloods, amniotic fluids if it is possible. They will be followed up to two years after the child delivery (6 weeks,6 months,1 years and 2years after the child delivery) and do the same sampling who have preeclampsia during gestation. The salivas, vaginal swabs,placentas, amniotic fluids and feces will be to perform 16S rRNA(ribosomal ribonucleic acid) gene sequencing microecology assessment, Body fluid samples will be to perform peptidomics by MALDI-TOF(Matrix-Assisted Laser Desorption/ Ionization Time of Flight ) and metabonomics by mass spectrometer, combinations of mean arterial pressure (MAP), uterine artery pulsatile index , serum placental growth factor (PlGF) to estimate the patient-specific risk of pre-eclampsia (PE) .

Interventions

  • Other Observational studies, The diagnosis was preeclampsia
    Observational studies, The diagnosis was preeclampsia

Primary outcome measures

  • microbiome [Time frame: 34 months]
  • proteomics [Time frame: 34 months]
  • metabonomics [Time frame: 34 months]
Secondary outcome measures (3)
  • microbiome [Time frame: 10 months]
  • proteomics [Time frame: 10 months]
  • metabonomics [Time frame: 10 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Zhujiang Hospital of Southern Medical University — Guangzhou
  • Zhujiang hospital — Guangzhou

Publications

  • Chen X, Li P, Liu M, Zheng H, He Y, Chen MX, Tang W, Yue X, Huang Y, Zhuang L, Wang Z, Zhong M, Ke G, Hu H, Feng Y, Chen Y, Yu Y, Zhou H, Huang L. Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation. Gut. 2020 Mar;69(3):513-522. doi: 10.1136/gutjnl-2019-319101. Epub 2020 Jan 3. PMID 31900289

Identifiers

NCT: NCT05445544 · CALM2001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗