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: June 2024
• 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 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.

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.

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 <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.

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	Present of maternal-vascular-malperfusion (MVM)-FGR	Development of MVM Fetal growth restriction	during the pregnancy, up to an average gestational age of 40 weeks
Secondary	Other adverse pregnancy outcome	including miscarriage, preeclampsia; intrauterine fetal death	pregnancy-born after 28 days
Secondary	GA at delivery, birth weight, neonatal outcomes.	GA at delivery, birth weight, neonatal outcomes.	the day at birth