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

NCT06104748 | Recruiting

• 1 other identifier: ShanghaiFMIH-FMU6
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

MVM-FGR

Keywords

FGR; maternal vascular malperfusion; Doppler; placenta; etiologies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Distribution of genetic etiologies of FGR

  the day at birth

• Severe maternal complications

  pregnancy-born after 28 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

severe FGR singletons

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Maternal serum and plasma samples will be used for omics analysis, amniotic fluid will underwent genetic testing (including karyotyping, chromosomal microarray analysis and exome sequencing), and/or infection testing. Placenta will perform pathological testing after delivery.

Study Officials

• Luming Sun, Doctor

  Department of Fetal Medicine, Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianping Chen, Master

CONTACT

+86 13916159565; urchin_chen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 27, 2023
• Study Start: August 10, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CN (1)