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

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).

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jianping Chen, Master; Phone Number: +86 13916159565; Email: urchin_chen@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201204
      • Recruiting
      • Shanghai First Maternity and Infant Hospital
      • Contact: Luming Sun, MD; PhD; Phone Number: 021-20261151; Email: luming_sun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

severe FGR singletons

Description

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.

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital
• Investigators: Principal Investigator: Luming Sun, Doctor, Department of Fetal Medicine, Shanghai First Maternity and Infant Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Doppler; placenta; FGR; maternal vascular malperfusion; etiologies
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Growth Retardation
• Other Study ID Numbers: ShanghaiFMIH-FMU6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No