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

Study Overview
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Brief Summary
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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
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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) .

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

Conditions
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Preeclampsia, Microbiome

Intervention / Treatment
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* Other: Observational studies, The diagnosis was preeclampsia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women and Follow-up of pregnant women's newborns<br>The pregnant woman is pregnant until she gives birth. The fecal ,serum,saliva,urine,vaginal secretions,umbilical cord blood,placenta and amniotic fluids who are were caesarean delivered will be collected | Other: Observational studies, The diagnosis was preeclampsia<br>* Observational studies, The diagnosis was preeclampsia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiome | To evaluate the predictive value of microbiome in preeclampsia. To observe the changes of microbiome in pregnant women with preeclampsia from 11-14 weeks of gestation to two years postpartum.The microbial composition of the stool samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. | 34 months | 
| proteomics | To evaluate the predictive value of proteomics in preeclampsia. To observe the changes of urine and serum proteomics in pregnant women with preeclampsia from 11-14 weeks of gestation to two years postpartum. proteomics is the large-scale study of small or big molecules, such as protein,polypeptide. | 34 months | 
| metabonomics | To evaluate the predictive value of metabonomics in preeclampsia. To observe the changes of serum metabonomics in pregnant women with preeclampsia from 11-14 weeks of gestation to two years postpartum. Metabolomics is the large-scale study of small molecules, such as fatty acids, bile acids, lipid mediators and others. | 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiome | To evaluate the value of microbiome in assessing pregnancy outcome (complications during pregnancy and delivery, delivery) . To observe the changes of microbiome in pregnant women from 11-14 weeks of gestation to delivery.The microbial composition of the stool samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. | 10 months | 
| proteomics | To evaluate the value of proteomics in assessing pregnancy outcome (complications during pregnancy and delivery, delivery) . To observe the changes of proteomics in pregnant women from 11-14 weeks of gestation to delivery.proteomics is the large-scale study of small or big molecules, such as protein,polypeptide. | 10 months | 
| metabonomics | To evaluate the value of metabonomics in assessing pregnancy outcome (complications during pregnancy and delivery, delivery) . To observe the changes of metabonomics in pregnant women from 11-14 weeks of gestation to delivery. Metabolomics is the large-scale study of small molecules, such as fatty acids, bile acids, lipid mediators and others. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia