Causal Relationship Between Plasma VEGF Family Proteins and Placenta Previa: A Two-Sample Mendelian Randomization Study (VEGF PP)

September 26, 2024 updated by: Zhibin Xu, Guangzhou Institute of Respiratory Disease

Causal Association Between Plasma Vascular Endothelial Growth Factor Family Proteins and Placenta Previa: A Two-Sample Mendelian Randomization Study

This study aims to investigate the causal relationship between plasma vascular endothelial growth factor (VEGF) family proteins and placenta previa using a two-sample Mendelian randomization (MR) approach. Genome-wide association study (GWAS) data will be analyzed to assess the correlation and potential causality between VEGF protein levels and the occurrence of placenta previa.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Detailed Description

Placenta previa is a serious complication during pregnancy, leading to significant risks for both the mother and the fetus. This study utilizes Mendelian randomization (MR) to explore the potential causal link between plasma levels of VEGF family proteins (including VEGFA, VEGFB, VEGFC, VEGFD, and PLGF) and the risk of placenta previa. By using genome-wide association study (GWAS) data from the UK Biobank and FinnGen datasets, the study aims to provide insights into the role of angiogenesis and abnormal placental development. The MR analysis will help minimize confounding factors and provide robust evidence regarding the causal relationship between VEGF proteins and placenta previa.

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 (Estimated)

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.
207473

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study analyzes data from European populations included in genome-wide association studies (GWAS) from UK Biobank and FinnGen, focusing on individuals with available plasma VEGF family protein levels and placenta previa data.

Description

Inclusion Criteria:

  • Participants included in genome-wide association studies (GWAS) with available data on plasma VEGF family proteins and placenta previa.

Exclusion Criteria:

  • Participants with incomplete or missing data on plasma VEGF levels or placenta previa.

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

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
Causal relationship between plasma VEGFA levels and the risk of placenta previa
Time Frame: Data analysis and outcome assessment will be completed by December 2024
This outcome measures the association between plasma VEGFA levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.
Data analysis and outcome assessment will be completed by December 2024

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
Causal relationship between plasma VEGFB levels and the risk of placenta previa
Time Frame: Data analysis and outcome assessment will be completed by December 2024
This outcome measures the association between plasma VEGFB levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.
Data analysis and outcome assessment will be completed by December 2024
Causal relationship between plasma VEGFC levels and the risk of placenta previa
Time Frame: Data analysis and outcome assessment will be completed by December 2024
This outcome measures the association between plasma VEGFC levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.
Data analysis and outcome assessment will be completed by December 2024
Causal relationship between plasma PLGF levels and the risk of placenta previa
Time Frame: Data analysis and outcome assessment will be completed by December 2024
This outcome measures the association between plasma PLGF levels (measured in picograms per milliliter) and the occurrence of placenta previa, using Mendelian Randomization (MR) analysis to assess causality.
Data analysis and outcome assessment will be completed by December 2024

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.
Guangzhou Institute of Respiratory Disease

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.
First People's Hospital of Foshan
The Second People's Hospital of Foshan
Maternal and Child Health Hospital of Foshan

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 (Estimated)

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.
September 25, 2024

Primary Completion (Estimated)

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.
November 1, 2024

Study Completion (Estimated)

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 1, 2024

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).
September 24, 2024

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.
September 26, 2024

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.
October 1, 2024

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.
October 1, 2024

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.
September 26, 2024

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.
September 1, 2024

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.
  • FSKY20240924

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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