Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)

Recruiting

• Conditions: Fetal Growth Retardation

• Registration Number: NCT06096805
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.

Detailed Description

Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Pregnant women with gestational age of <14 weeks

• Maternal age between 18 and 45 years old

• With at least one of FGR high risk factors:

  1. Maternal age >40 years
  2. Nulliparous, Maternal age >38 years
  3. Previous pregnancy with FGR, PE or placental abruption
  4. Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
  5. Recurrent spontaneous abortion (RSA) > 3 times with unknown causes

• Or with at least two of the following FGR high risk factors:

  1. Maternal age 35~40 years
  2. BMI ≥ 28 kg/m2 or BMI < 18.5 kg/m2
  3. Conception with assisted reproductive technology
  4. Interval from previous delivery: > 5 years or < 6 months

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Exclusion Criteria

• Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Present of maternal-vascular-malperfusion (MVM)-FGR	during the pregnancy, up to an average gestational age of 40 weeks	Development of MVM Fetal growth restriction

Secondary Outcome Measures

Name	Time	Method
Other adverse pregnancy outcome	pregnancy-born after 28 days	including miscarriage, preeclampsia; intrauterine fetal death
GA at delivery, birth weight, neonatal outcomes.	the day at birth	GA at delivery, birth weight, neonatal outcomes.

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China