A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
ConditionMVM-FGR
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorShanghai First Maternity and Infant Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
Disqualifiers
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
Trial population
severe FGR singletons
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
during the pregnancy, up to an average gestational age of 40 weeks2
predictive model for adverse outcomes
Development of a predictive model for adverse outcomes of MVM-FGR through the integration of maternal and fetal indicators
Time frame
death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birthSecondary outcomes
1
Distribution of genetic etiologies of FGR
Distribution of genetic etiologies of FGR under the standard assessment process.
Time frame
the day at birth2
Severe maternal complications
Severe maternal complications in MVM-FGR cohort
Time frame
pregnancy-born after 28 daysSponsors and contacts
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Source ClinicalTrials.gov