A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)

Last updated: June 6, 2024
Sponsor: Shanghai First Maternity and Infant Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Birth Defects

Treatment

N/A

Clinical Study ID

NCT06104748
ShanghaiFMIH-FMU6
  • Ages 18-45
  • Female

Study 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 conducted to seek predictive indicators for short-term and long-term adverse outcomes of maternal vascular malperfusion-related FGR (MVM-FGR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

1.Singleton pregnancy 2. diagnosed as FGR according the delphi consensus:

  1. Early-onset FGR(<32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd; or EFW or AC < 10th, combined with abnormal doppler, including uterineartery pulsatility index(UtA PI) >95th percentile, umbilical artery pulsatilityindex(UA PI) >95th percentile； or umbilical artery absent end-diastolic flow (UA-AEDF) or umbilical artery reversed end-diastolic flow(UA-REDF).

  2. 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 writteninformed consent.

Exclusion

Exclusion Criteria:

  • Fetus with definitive genetic disorders related to FGR, fetus with confirmedintrauterine infection (CMV, syphilis and etc.), fetus with structural anomalies

  • Incomplete information or absence of informed consent

Study Design

Total Participants: 500
Study Start date:
August 10, 2023
Estimated Completion Date:
December 30, 2025

Study 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 morbidity and mortality during the perinatal phase, intricately linked with adverse long-term consequences. The etiology of FGR is complex, involving maternal, placental/umbilical, and fetal factors. Among these, maternal vascular malperfusion-related FGR (MVM-FGR) emerges as the prevalent subtype, which is considered to have potential for early intervention and prevention.

To address this, we will establish a cohort dedicated to MVM-FGR, guided by a stringent diagnostic standard process tailored for FGR. Our objective is to compile a comprehensive dataset of singleton pregnancies diagnosed with MVM-FGR cases through multicenter collaboration. The definition of FGR aligns with the FIGO consensus criteria. We conduct thorough prenatal screenings for fetal factors, including genetic abnormalities, infections, and structural anomalies, subsequently enrolling MVM-FGR cases into our cohort.

Techniques including Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring will be employed to assess fetal conditions. Follow-up continues until the child reaches the age of two years postpartum. Pathological examination of the placenta is performed after delivery, with additional placental genetic testing if necessary.

Connect with a study center

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai 201204
    China

    Active - Recruiting

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