Status:
RECRUITING
A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
Lead Sponsor:
Shanghai First Maternity and Infant Hospital
Conditions:
MVM-FGR
Eligibility:
FEMALE
18-45 years
Brief Summary
Based on a precise diagnostic standard process, through a multicenter study, we will establish a cohort focusing on placenta-mediated fetal growth restriction (FGR). Long-term follow-up will be conduc...
Detailed Description
Fetal Growth Restriction (FGR) denotes the inability of fetal growth to attain its inherent genetic potential due to diverse pathological influences. It stands as a significant determinant of morbidit...
Eligibility Criteria
Inclusion
- Singleton pregnancy 2. diagnosed as FGR according the delphi consensus:
- Early-onset FGR(\<32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) \< 3rd; or EFW or AC \< 10th, combined with abnormal doppler, including uterine artery pulsatility index(UtA PI) \>95th percentile, umbilical artery pulsatility index(UA PI) \>95th percentile； or umbilical artery absent end-diastolic flow (UA-AEDF) or umbilical artery reversed end-diastolic flow(UA-REDF).
- Late-onset FGR(≥32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) \< 3rd; or \>2 of the following 3 criteria:
- EFW or AC \<10th percentile
- EFW or AC crossing percentiles\>2 quartiles on growth percentiles
- CPR \<5th percentile or UA-Pl\>95th percentile 3.provision of signed written informed consent.
Exclusion
- Fetus with definitive genetic disorders related to FGR, fetus with confirmed intrauterine infection (CMV, syphilis and etc.), fetus with structural anomalies
- Incomplete information or absence of informed consent
Key Trial Info
Start Date :
August 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06104748
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