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

February 3, 2023 updated by: Hongwei Zhou, Zhujiang Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
microbiome
Time Frame: 34 months
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
Time Frame: 34 months
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
Time Frame: 34 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
microbiome
Time Frame: 10 months
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
Time Frame: 10 months
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
Time Frame: 10 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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