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

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Microbiome
• Intervention / Treatment: Other: Observational studies, The diagnosis was preeclampsia

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510000
      • Recruiting
      • Zhujiang Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhujiang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All the patients in pregnancy will be eligible to be enrolled.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Nanfang Hospital of Southern Medical University; First Affiliated Hospital of Wenzhou Medical University; Tianjin Central Hospital of Gynecology Obstetrics; Northwest Women's and Children's Hospital, Xi'an, Shaanxi; Foshan Women and Children Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2022
• Primary Completion (ANTICIPATED): December 31, 2027
• Study Completion (ANTICIPATED): December 31, 2027

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (ACTUAL): July 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: preeclampsia
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CALM2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No