Status:
RECRUITING
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Lead Sponsor:
Shanghai First Maternity and Infant Hospital
Conditions:
Fetal Growth Retardation
Eligibility:
FEMALE
18-45 years
Brief 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 bio...
Detailed 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 screenin...
Eligibility Criteria
Inclusion
- 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:
- Maternal age \>40 years
- Nulliparous, Maternal age \>38 years
- Previous pregnancy with FGR, PE or placental abruption
- Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
- Recurrent spontaneous abortion (RSA) \> 3 times with unknown causes
- Or with at least two of the following FGR high risk factors:
- Maternal age 35\~40 years
- BMI ≥ 28 kg/m2 or BMI \< 18.5 kg/m2
- Conception with assisted reproductive technology
- Interval from previous delivery: \> 5 years or \< 6 months
Exclusion
- Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06096805
Start Date
August 10 2023
End Date
December 30 2025
Last Update
June 7 2024
Active Locations (1)
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1
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 201204