Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 900
- 主要终点
- Composite adverse pregnancy outcomes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with singleton pregnancy;
- •Undergo non-invasive prenatal testing (NIPT) at 12-14 weeks of gestation at the Second Affiliated Hospital of Wenzhou Medical University;
- •Plan to deliver at the same hospital;
- •Have complete clinical data and provide written informed consent.
排除标准
- •Age ≥40 years or <18 years, BMI ≥30 or <18.5, multiple pregnancy, or history of adverse pregnancy outcomes;
- •Diagnosed autoimmune diseases, chronic hypertension, diabetes mellitus, or chronic kidney disease;
- •Infection or fever during pregnancy;
- •History of smoking or alcohol abuse, recent surgery or trauma, or use of glucocorticoids or immunosuppressants;
- •Other conditions that may cause abnormal nucleosome or placental growth factor (PLGF) levels.
研究组 & 干预措施
Normal nucleosome and PLGF group
Normal nucleosome and PLGF group
干预措施: Measurement of plasma nucleosome and placental growth factor (PLGF) levels (Other)
Nucleosome-elevated only group
Nucleosome-elevated only group
干预措施: Measurement of plasma nucleosome and placental growth factor (PLGF) levels (Other)
PLGF-elevated only group
PLGF-elevated only group
干预措施: Measurement of plasma nucleosome and placental growth factor (PLGF) levels (Other)
Nucleosome and PLGF elevated group
Nucleosome and PLGF elevated group
干预措施: Measurement of plasma nucleosome and placental growth factor (PLGF) levels (Other)
结局指标
主要结局
Composite adverse pregnancy outcomes
时间窗: From enrollment (12-14 weeks of gestation) to delivery (up to 40 weeks of gestation).
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.
次要结局
- Preeclampsia(From 20 weeks of gestation to delivery (up to 40 weeks of gestation).)
- Fetal Growth Restriction (FGR)(From 20 weeks of gestation to delivery.)
- Preterm Birth(From 20 weeks of gestation to delivery.)
- Spontaneous Abortion (Miscarriage)(From enrollment (12-14 weeks of gestation) to 20 weeks of gestation.)
- Low Birth Weight(At delivery.)
研究者
Ying Hua
Director of department
Second Affiliated Hospital of Wenzhou Medical University