Actively Recruiting
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Led by Shanghai First Maternity and Infant Hospital · Updated on 2024-06-07
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a study to develop a predictive model for placental maternal vascular malperfusion (MVM) leading to fetal growth restriction (FGR) in pregnant women who are considered high risk. The study aims to improve early identification of FGR by combining maternal medical history, ultrasound data, and biological markers from maternal serum and plasma. This research addresses limitations of current prediction methods, which are often based on models for preeclampsia or Down syndrome and may not be effective for FGR. Pregnant women at high risk for FGR will be enrolled before 14 weeks of gestation. Data collection includes maternal baseline characteristics, ultrasound measurements of fetal growth and blood flow, and blood samples taken during the first and mid-trimester for biomarker testing. Researchers will observe fetal growth and maternal-fetal complications throughout pregnancy, and after birth, they will gather delivery details, newborn condition, and placental pathology results. The goal is to create a combined model using all these factors to predict early and mid-term MVM-FGR. Participants will be followed through pregnancy with regular evaluations including ultrasound scans and blood tests. Information about birth outcomes and any complications will be recorded. The main outcome measured is the presence of MVM-FGR during pregnancy up to about 40 weeks gestation. Secondary outcomes include other adverse pregnancy events after 28 days, delivery timing, birth weight, and neonatal health. The study will continue until after delivery to collect comprehensive data on maternal and fetal health.
CONDITIONS
Brief Title
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with gestational age less than 14 weeks
- Maternal age between 18 and 45 years old
- Have at least one high-risk factor for fetal growth restriction including:
- Maternal age over 40 years
- First pregnancy with maternal age over 38 years
- Previous pregnancy with fetal growth restriction, preeclampsia, or placental abruption
- Maternal history of chronic hypertension, diabetes, chronic nephritis, or autoimmune diseases such as SLE or APS
- Recurrent spontaneous abortion more than 3 times with unknown causes
- Or have at least two of the following high-risk factors:
- Maternal age between 35 and 40 years
- Body mass index 28 kg/m2 or higher, or below 18.5 kg/m2
- Conception using assisted reproductive technology
- Interval from previous delivery more than 5 years or less than 6 months
You will not qualify if you...
- Presence of fetal genetic abnormalities
- Severe structural abnormalities found in prenatal ultrasound or genetic testing
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment up to delivery (approximately up to 26 weeks or more depending on gestational age at enrollment)
Participants are regularly observed through ultrasound measurements, Doppler blood flow assessments, and biomarker testing during pregnancy to track fetal growth and maternal-fetal health.
Multiple visits for ultrasound and blood sample collection during first and mid-trimester
Duration - Up to delivery and shortly after birth
Participants are observed for maternal-fetal complications during pregnancy and delivery outcomes, including newborn conditions and placental pathology.
Visits at delivery and post-delivery assessments
Trial Site Locations
Total: 1 location
1
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 201204
Actively Recruiting
Research Team
J
Jianping Chen, Master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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