Clinical trial NCT05445544: A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Official title: A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Microbiome
Keywords: preeclampsia
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Foshan Women's and Children's Hospital
name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2022-07-06
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients in pregnancy will be eligible to be enrolled.

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.

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) .

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.

Primary outcomes:
measure: microbiome
timeFrame: 34 months
measure: proteomics
timeFrame: 34 months
measure: metabonomics
timeFrame: 34 months
Secondary outcomes:
measure: microbiome
timeFrame: 10 months
measure: proteomics
timeFrame: 10 months
measure: metabonomics
timeFrame: 10 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang hospital
state: Guang Dong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: hongwei zhou
role: STUDY_CHAIR
References:
citation: 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.