A Cohort of Severe Placental Fetal Growth Restriction (CoSFGR)

Fetal Growth Restriction Clinical Trial

Official title:

A Cohort for Severe Placental Fetal Growth Restriction (CoSFGR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104748
• Other study ID #: ShanghaiFMIH-FMU6
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Jianping Chen, Master
• Phone: +86 13916159565
• Email: urchin_chen[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Through multicenter study, the investigators aim to refine the process for precise prenatal diagnosis of fetal growth restriction (FGR), establish a cohort for severe maternal vascular malperfusion (MVM)-FGR, and conduct follow-up study to identify prognostic factors associated with both short-term and long-term outcomes.

Description:

FGR refers to the inadequate growth of the fetus due to various pathological factors, and is a major cause of morbidity and mortality in neonates, with close link to adverse long-term outcomes. This cohort will based on the establishment of a precise prenatal diagnostic process for FGR, and aims to establish a cohort for severe MVM-FGR. Severe singleton FGR cases (EFW or AC<3%, or EFW<10% with abnormal doppler blood flow) from multiple centers will be included. Prenatal genetic and microbial testing, and ultrasound will be performed to rule out associated fetal factors. Fetal intrauterine status will be closely monitored and assessed during pregnancy, with follow-up studies conducted up to 2 years of age. Pathological examination of the placenta will be conducted after delivery, with genetic testing when necessary.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Singleton pregnancy

2. 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).

3. provision of signed written informed consent.

Exclusion Criteria:

1. Fetus with congenital anomalies;

2. fetus with suspected chromosomal or single gene disorders;

3. fetus with confirmed intrauterine infection (CMV, syphilis and etc.);

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of etiology in severe FGR fetuses	genetic, maternal or placenta	during the pregnancy, up to an average gestational age of 40 weeks
Primary	Incidence of perinatal death of MVM-FGR	Incidence of intrauterine Fetal death (IUFD) or neonatal death	death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth
Secondary	Gestational age at birth	Gestational age at birth	the day at birth
Secondary	Neonatal morbidities	including bronchopulmonary dysplasia, necrotizing enterocolitis,hypoxic ischemic encephalopathy and etc.	pregnancy-born after 28 days
Secondary	birthweight	birthweight of the neonate	the day at birth
Secondary	incidence of abnormal neurodevelopment	incidence of any abnormal neurodevelopment diagnosed by doctor.	2 years after birth