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

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096805
• Other study ID #: ShanghaiFMIH-FMU7
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Jianping Chen, Master
• Phone: 13916159565
• Email: urchin_chen[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Retardation

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Fetal growth restriction	Development of Fetal growth restriction	during the pregnancy, up to an average gestational age of 40 weeks
Secondary	Birth weight	Birth weight of the neonate	the day at birth
Secondary	incidence of other adverse pregnancy outcomes	including miscarriage, preeclampsia, and intrauterine fetal death;	pregnancy-born after 28 days