A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China (CALM2001)

Zhujiang Hospital

Status: Enrolling

Conditions: Preeclampsia; Microbiome

Treatments: Other: Observational studies, The diagnosis was preeclampsia

Study type: Observational

Funder types: Other

Identifiers

NCT05445544

CALM2001

Details and patient eligibility

About

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.

Full 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) .

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10,000 participants in 1 patient group

Pregnant women and Follow-up of pregnant women's newborns

Description:

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

Treatment:

Other: Observational studies, The diagnosis was preeclampsia