Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes

N/ANot Yet RecruitingNCT07841197

Second Affiliated Hospital of Wenzhou Medical University900 enrolled

Overview

Objective: This study aims to investigate the association between maternal serum placental growth factor (PLGF) and nucleosome levels in early pregnancy and adverse pregnancy outcomes, and to evaluate their predictive value for the occurrence of preeclampsia, fetal growth restriction, preterm birth, and other pregnancy complications. Method: This observational prospective cohort study enrolls pregnant women who undergo non-invasive prenatal testing (NIPT) at 12-14 weeks of gestation and deliver at the Second Affiliated Hospital of Wenzhou Medical University between June 2026 and July 2027. Maternal peripheral blood samples are collected for NIPT analysis, and plasma nucleosome concentrations and PLGF levels are measured. Participants are categorized into four groups based on the 95th percentile (P95) of nucleosome and PLGF levels established from a healthy pregnant population at the same center during the same period: (1) both normal, (2) elevated nucleosome only, (3) elevated PLGF only, and (4) both elevated. Maternal demographic characteristics, laboratory indicators, and pregnancy outcomes are collected and compared across groups. The incidence of adverse pregnancy outcomes, including preeclampsia, fetal growth restriction, preterm birth, recurrent miscarriage, and neonatal complications, is recorded. The relationship between nucleosome and PLGF levels and adverse pregnancy outcomes is analyzed to explore their potential as early predictive biomarkers for placental dysfunction-related complications.

Study Type

OBSERVATIONAL

Enrollment

900

Conditions

Preeclampsia Premature Birth Fetal Growth Restriction

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pregnant women with singleton pregnancy; 2. Undergo non-invasive prenatal testing (NIPT) at 12-14 weeks of gestation at the Second Affiliated Hospital of Wenzhou Medical University; 3. Plan to deliver at the same hospital; 4. Have complete clinical data and provide written informed consent. Exclusion Criteria: 1. Age ≥40 years or \<18 years, BMI ≥30 or \<18.5, multiple pregnancy, or history of adverse pregnancy outcomes; 2. Diagnosed autoimmune diseases, chronic hypertension, diabetes mellitus, or chronic kidney disease; 3. Infection or fever during pregnancy; 4. History of smoking or alcohol abuse, recent surgery or trauma, or use of glucocorticoids or immunosuppressants; 5. Other conditions that may cause abnormal nucleosome or placental growth factor (PLGF) levels.

Outcomes

Primary Outcomes

Composite adverse pregnancy outcomes

Incidence of preeclampsia, fetal growth restriction (FGR), preterm birth, stillbirth, or spontaneous abortion. The occurrence of any one of these events is defined as the composite adverse pregnancy outcome.

Time frame: From enrollment (12-14 weeks of gestation) to delivery (up to 40 weeks of gestation).

Secondary Outcomes

Preeclampsia

Incidence of preeclampsia, defined as new-onset hypertension (blood pressure \>= 140/90 mmHg) after 20 weeks of gestation accompanied by proteinuria or maternal organ dysfunction.

Time frame: From 20 weeks of gestation to delivery (up to 40 weeks of gestation).

Fetal Growth Restriction (FGR)

Incidence of fetal growth restriction, defined as an estimated fetal weight or abdominal circumference below the 10th percentile for gestational age, confirmed by postnatal birth weight.

Time frame: From 20 weeks of gestation to delivery.

Preterm Birth

Incidence of preterm birth, defined as delivery before 37 completed weeks of gestation.

Time frame: From 20 weeks of gestation to delivery.

Spontaneous Abortion (Miscarriage)

Incidence of spontaneous abortion, defined as natural pregnancy loss before 20 weeks of gestation. (Note: Induced abortion is excluded).

Time frame: From enrollment (12-14 weeks of gestation) to 20 weeks of gestation.

Low Birth Weight

Incidence of low birth weight, defined as neonatal birth weight less than 2500 grams.

Time frame: At delivery.