Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Outcome Measures
Primary Outcome Measures
- Development of Fetal growth restriction [during the pregnancy, up to an average gestational age of 40 weeks]
Development of Fetal growth restriction
Secondary Outcome Measures
- Birth weight [the day at birth]
Birth weight of the neonate
- incidence of other adverse pregnancy outcomes [pregnancy-born after 28 days]
including miscarriage, preeclampsia, and intrauterine fetal death;
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai First Maternity and Infant Hospital | Shanghai | Shanghai | China | 201204 |
Sponsors and Collaborators
- Shanghai First Maternity and Infant Hospital
Investigators
- Principal Investigator: Luming Sun, Docter, Shanghai First Maternity and Infant Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ShanghaiFMIH-FMU7