About this trial
The goal of this prospective cohort study is to enroll pregnancies complicated by placental-related fetal growth restriction (FGR) and to develop predictive models for adverse short- and long-term outcomes. This will be achieved by collecting novel intrauterine monitoring indicators along the fetal brain-placenta-heart axis, combined with conventional fetal surveillance parameters, in order to improve risk stratification and guide clinical management, ultimately improving pregnancy outcomes.
The study will include pregnant women with singleton pregnancies complicated by isolated early-onset placental insufficiency-related FGR, preferably those with abnormal umbilical artery Doppler findings, who elect to continue the pregnancy.
The main question it aims to answer is:
• Whether a predictive model integrating novel intrauterine monitoring indicators along the fetal brain-placenta-heart axis with conventional monitoring parameters can accurately predict perinatal and neonatal adverse outcomes in pregnancies complicated by placental-related FGR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton pregnancy.
Isolated early-onset placental insufficiency-related fetal growth restriction (FGR), with priority given to cases with abnormal umbilical artery Doppler flow.
Pregnancies in which expectant management is continued.
Disqualifiers
Multiple pregnancy complicated by selective fetal growth restriction (sFGR).
FGR caused by fetal structural anomalies, genetic abnormalities, or intrauterine infection.
Twin pregnancy with intrauterine fetal demise (IUFD) of one fetus.
Trial population
singleton pregnancies complicated by isolated early-onset placental insufficiency-related FGR, preferably those with abnormal umbilical artery Doppler findings, who elect to continue the pregnancy.
Trial design
Cohort
Prospective
Treatments tested in this trial
new ultrasound index and MRI
Other intervention1. Fetal Growth Measurements (every 2 w after FGR diagnosis): * Initial diagnosis and follow-up visits * BPD/HC/AC/FL * DVP/AFI * Placental thickness * Umbilical cord insertion site 2. Conventional Doppler Measurements (at least every 2 w after FGR diagnosis): * UA-PI * AEDF * REDF * MCA-PI * MCA-PSV * CPR; MCA-PI / UA-PI * DV-PI * Absent a-wave * Reversed a-wave * UtA Doppler * Left PI and presence of left notch * Right PI and presence of right notch 3. Research Ultrasound Assessments * Placental MV-Flow: vascular index (VI) - upper, middle, and lower regions * Fetal heart \- Cardiothoracic ratio (area ratio) \- Myocardial performance index (MPI): LV-MPI RV-MPI \- E/A ratio: Mitral valve (MV-E/A) Tricuspid valve (TV-E/A) * Fetal brain * Development of the Sylvian fissure: present or absent 3.4 Fetal Brain MRI at 28-30 Weeks of Gestation
Treatment groups
Trial outcomes
Primary outcomes
pregnancy outcome
Sponsors and contacts
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