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

Обзор

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.

Подробное описание

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) .

Вмешательства

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

Первичные конечные точки

• microbiome [Срок оценки: 34 months]
• proteomics [Срок оценки: 34 months]
• metabonomics [Срок оценки: 34 months]

Вторичные конечные точки (3)

• microbiome [Срок оценки: 10 months]
• proteomics [Срок оценки: 10 months]
• metabonomics [Срок оценки: 10 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Zhujiang Hospital of Southern Medical University — Гуанчжоу
• Zhujiang hospital — Гуанчжоу

Публикации

• 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

Идентификаторы

NCT: NCT05445544 · CALM2001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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