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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2025-12-30

Brief Summary

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This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.

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Detailed Description

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Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.

Conditions

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Fetal Growth Retardation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with gestational age of \<14 weeks
* Maternal age between 18 and 45 years old
* With at least one of FGR high risk factors:

1. Maternal age \>40 years
2. Nulliparous, Maternal age \>38 years
3. Previous pregnancy with FGR, PE or placental abruption
4. Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
5. Recurrent spontaneous abortion (RSA) \> 3 times with unknown causes
* Or with at least two of the following FGR high risk factors:

1. Maternal age 35\~40 years
2. BMI ≥ 28 kg/m2 or BMI \< 18.5 kg/m2
3. Conception with assisted reproductive technology
4. Interval from previous delivery: \> 5 years or \< 6 months