AI-Based Ultrasound Prediction of Pregnancy Outcomes in Placental-Related Fetal Growth Restriction (MVM-FGR): A Prospective Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-43
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • new ultrasound index and MRI

    Other intervention

    1. 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

300 Participants
are divided into 1 treatment group
Group A: FGR group1 intervention

Trial outcomes

Primary outcomes

1

pregnancy outcome

Time frame
during the whole pregnancy and born within 28 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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