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A Cohort of Severe Placental Fetal Growth Restriction (CoSFGR)

Sponsor
Shanghai First Maternity and Infant Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06104748
Collaborator
(none)
500
Enrollment
1
Location
28.7
Anticipated Duration (Months)
17.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Cohort for Severe Placental Fetal Growth Restriction (CoSFGR)
    Actual Study Start Date :
    Aug 10, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2025
    Anticipated Study Completion Date :
    Dec 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Distribution of etiology in severe FGR fetuses [during the pregnancy, up to an average gestational age of 40 weeks]

      genetic, maternal or placenta

    2. Incidence of perinatal death of MVM-FGR [death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth]

      Incidence of intrauterine Fetal death (IUFD) or neonatal death

    Secondary Outcome Measures

    1. Gestational age at birth [the day at birth]

      Gestational age at birth

    2. Neonatal morbidities [pregnancy-born after 28 days]

      including bronchopulmonary dysplasia, necrotizing enterocolitis,hypoxic ischemic encephalopathy and etc.

    3. birthweight [the day at birth]

      birthweight of the neonate

    4. incidence of abnormal neurodevelopment [2 years after birth]

      incidence of any abnormal neurodevelopment diagnosed by doctor.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.);

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai First Maternity and Infant Hospital Shanghai Shanghai China 201204

    Sponsors and Collaborators

    • Shanghai First Maternity and Infant Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luming Sun, Professor, Shanghai First Maternity and Infant Hospital
    ClinicalTrials.gov Identifier:
    NCT06104748
    Other Study ID Numbers:
    • ShanghaiFMIH-FMU6
    First Posted:
    Oct 27, 2023
    Last Update Posted:
    Oct 27, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Luming Sun, Professor, Shanghai First Maternity and Infant Hospital
    FGR
    MVM
    Doppler
    placenta
    Additional relevant MeSH terms:
    Fetal Growth Retardation

    Study Results

    No Results Posted as of Oct 27, 2023