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

Launched by SHANGHAI FIRST MATERNITY AND INFANT HOSPITAL · Oct 23, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Prediction of Placental Fetal Growth Restriction in High Risk Population" (PoPFGR) is studying ways to predict if a baby might not be growing properly in the womb, particularly for women who are considered high-risk. The researchers are looking to enroll pregnant women who are less than 14 weeks along and fall into certain categories that could increase the risk of fetal growth issues. This includes women over 40, those who have had complications in previous pregnancies, or those with certain health conditions like high blood pressure or diabetes.

If you are a pregnant woman between the ages of 18 and 45 and meet the eligibility criteria, you may be invited to participate. Throughout the study, you will provide information about your health, undergo early pregnancy ultrasounds, and have some blood tests. The goal is to create a combined model that helps healthcare providers better predict and manage potential growth issues in babies, allowing for more tailored care during pregnancy. It’s important to note that women with certain serious fetal conditions will not be eligible for this study.

Gender

FEMALE

Eligibility criteria

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