Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)

October 23, 2023 updated by: Luming Sun, Shanghai First Maternity and Infant Hospital
This study aims to establish a multicenter cohort of FGR high-risk pregnant women, and aims to construct a combined predictive model for FGR by combining basic characteristics, medical history, early pregnancy ultrasound, and biomarkers.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Most FGR predictions are based on early pregnancy screening models for preeclampsia or mid-pregnancy screening models for Down syndrome, which have limited value. And specially clinical screening for maternal vascular malperfusion fetal growth restriction (MVM-FGR) in the general population was not recommended by most guidelines. This study aims to establish a multicenter, prospective cohort of FGR high-risk pregnant women. Baseline characteristics, and prenatal ultrasound evaluations of fetal growth, placental and maternal-fetal Doppler blood flow, and structural assessments, will be collected. Maternal serum and plasma will also be collected for biomarker testing. Fetal growth, information on pregnancy status, delivery information, and placental pathology test results will be collected. By combining medical history, ultrasound, serum, and plasma biomarkers, we will establish an combined predictive model for prediction of MVM-FGR at early pregnancy.

Study Type

Observational

Enrollment (Estimated)

2000

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201204
        • Recruiting
        • Shanghai First Maternity and Infant Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

First trimester pregnancy women who are at higher risk of fetal growth restriction.

Description

Inclusion Criteria:

  • Pregnant women with gestational age of <10 weeks, maternal age between 18 and 45 years old; and with presence of at least one of FGR high risk factors: maternal age≥40；or maternal age ≤20； or maternal age≥38 and primipara; or Chronic hypertension or diabetes; or pregnancy history of FGR, preeclampsia, unknown stillbirth, or placental abruption; between Aug 2023 and Dec 2025.

Exclusion Criteria:

  • Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
  • Presence of a serious acute or chronic illness.

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

Outcome Measure
Measure Description
Time Frame
Development of Fetal growth restriction
Time Frame: during the pregnancy, up to an average gestational age of 40 weeks
Development of Fetal growth restriction
during the pregnancy, up to an average gestational age of 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth weight
Time Frame: the day at birth
Birth weight of the neonate
the day at birth
incidence of other adverse pregnancy outcomes
Time Frame: pregnancy-born after 28 days
including miscarriage, preeclampsia, and intrauterine fetal death;
pregnancy-born after 28 days

Collaborators and Investigators

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

Sponsor

Shanghai First Maternity and Infant Hospital

Investigators

  • Principal Investigator: Luming Sun, Docter, Shanghai First Maternity and Infant Hospital

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)

August 10, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH-FMU7

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.

Clinical Trials on Fetal Growth Retardation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe