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

Recruiting

• Conditions: MVM-FGR

• Registration Number: NCT06104748
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

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

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 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.

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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 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).

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 written informed consent.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
short-term and long-term outcomes associated with MVM-FGR	during the pregnancy, up to an average gestational age of 40 weeks	Exploration of short-term and long-term outcomes associated with MVM-FGR, encompassing intrauterine fetal demise, neonatal mortality, and severe neonatal morbidity.
predictive model for adverse outcomes	death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth	Development of a predictive model for adverse outcomes of MVM-FGR through the integration of maternal and fetal indicators

Secondary Outcome Measures

Name	Time	Method
Severe maternal complications	pregnancy-born after 28 days	Severe maternal complications in MVM-FGR cohort
Distribution of genetic etiologies of FGR	the day at birth	Distribution of genetic etiologies of FGR under the standard assessment process.

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China