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

Shanghai First Maternity and Infant Hospital

Status: Enrolling

Conditions: Fetal Growth Retardation

Study type: Observational

Funder types: Other

Identifiers

NCT06096805

ShanghaiFMIH-FMU7

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

     Exclusion Criteria:

• Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.