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

Preeclampsia Clinical Trial

— CALM2001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445544
• Other study ID #: CALM2001
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2023
• Source: Zhujiang Hospital
• Contact: Sihua Qin
• Phone: 15622136950
• Email: 274896180[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Microbiome
• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• Observational studies, The diagnosis was preeclampsia
Observational studies, The diagnosis was preeclampsia

Locations

Country	Name	City	State
China	Zhujiang hospital	Guangzhou	Guang Dong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (6)

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

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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