CALM2001: A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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) .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnant women and Follow-up of pregnant women's newborns 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
Observational studies, The diagnosis was preeclampsia
|
Outcome Measures
Primary Outcome Measures
- microbiome [34 months]
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.
- proteomics [34 months]
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.
- metabonomics [34 months]
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.
Secondary Outcome Measures
- microbiome [10 months]
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.
- proteomics [10 months]
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.
- metabonomics [10 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged >=18 years;
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Pregnancy woman;
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With a singleton pregnancy;
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Volunteer and receive regular antenatal examinations in the research centers;
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Volunteer to sign a written informed consent.
Exclusion Criteria:
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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;
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With history of preeclampsia;
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Tumor patients concurrent with serious infection requiring long-term drug treatment;
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Pregnant women conceiving through in vitro fertilization;
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Multiple pregnancies;
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Patients with clear indications of medical pregnancy termination during early pregnancy;
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Any medical or non-medical conditions deemed inappropriate for study participation according to the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhujiang hospital | Guangzhou | Guang Dong | China | 510000 |
Sponsors and Collaborators
- Zhujiang Hospital
- Nanfang Hospital of Southern Medical University
- Tianjin Central Hospital of Gynecology Obstetrics
- Foshan Women and Children Hospital
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Investigators
- Study Chair: hongwei zhou, Zhujiang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- CALM2001