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

NCT05445544 | Recruiting

• 1 other identifier: CALM2001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Preeclampsia; Microbiome

Keywords

preeclampsia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• microbiome

  10 months

• proteomics

  10 months

• metabonomics

  10 months

Study Arms (1)

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

Interventions

Observational studies, The diagnosis was preeclampsia OTHER

Observational studies, The diagnosis was preeclampsia

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Preeclampsia is a condition in women during pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Zhujiang hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31900289 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen will include urines ,serums ,salivas, feces,vaginal swabs and placentas, cord bloods and amniotic fluids from the volunteers

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• hongwei zhou

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Sihua Qin

CONTACT

15622136950; 274896180@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 6, 2022
• Study Start: October 19, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)