Clinical trial NCT06104748: A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
Official title: A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MVM-FGR
Keywords: FGR
maternal vascular malperfusion
Doppler
placenta
etiologies
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe FGR singletons

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: short-term and long-term outcomes associated with MVM-FGR
timeFrame: during the pregnancy, up to an average gestational age of 40 weeks
measure: predictive model for adverse outcomes
timeFrame: death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth
Secondary outcomes:
measure: Distribution of genetic etiologies of FGR
timeFrame: the day at birth
measure: Severe maternal complications
timeFrame: pregnancy-born after 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
affiliation: Department of Fetal Medicine, Shanghai First Maternity and Infant Hospital
name: Luming Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
References: