Clinical trial NCT06096805: Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Official title: Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Growth Retardation
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First trimester pregnancy women who are at higher risk of fetal growth restriction.

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.

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.

Primary outcomes:
measure: Present of maternal-vascular-malperfusion (MVM)-FGR
timeFrame: during the pregnancy, up to an average gestational age of 40 weeks
Secondary outcomes:
measure: Other adverse pregnancy outcome
timeFrame: pregnancy-born after 28 days
measure: GA at delivery, birth weight, neonatal outcomes.
timeFrame: the day at birth
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
affiliation: Shanghai First Maternity and Infant Hospital
name: Luming Sun, Docter
role: PRINCIPAL_INVESTIGATOR
References: