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

NCT07841197 — Not yet recruiting, 900 participants, Second Affiliated Hospital of Wenzhou Medical University

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Registry	NCT07841197
Status	Not yet recruiting
Study type	Observational
Enrollment	900 (Estimated)
Sponsor	Second Affiliated Hospital of Wenzhou Medical University (Other)
Conditions	Preeclampsia, Premature Birth, Fetal Growth Restriction, Recurrent Miscarriage
Interventions	Measurement of plasma nucleosome and placental growth factor (PLGF) levels (Other)
Dates	start 2026-09-20 (estimated), primary completion 2027-07-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-09-25, last updated 2026-09-25

-Summary

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.

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+Arms and interventions

Arm	Interventions	Description
Normal nucleosome and PLGF group	Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels	Normal nucleosome and PLGF group
Nucleosome-elevated only group	Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels	Nucleosome-elevated only group
PLGF-elevated only group	Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels	PLGF-elevated only group
Nucleosome and PLGF elevated group	Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels	Nucleosome and PLGF elevated group

Measurement of plasma nucleosome and placental growth factor (PLGF) levels (Other): Maternal peripheral blood samples are collected at 12-14 weeks of gestation during routine non-invasive prenatal testing (NIPT). Plasma nucleosome concentrations and PLGF levels are measured to evaluate their association with adverse pregnancy outcomes.

+Outcome measures

Primary outcomes

Composite adverse pregnancy outcomes [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.

Secondary outcomes

Preeclampsia [From 20 weeks of gestation to delivery (up to 40 weeks of gestation).]: 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.
Fetal Growth Restriction (FGR) [From 20 weeks of gestation to delivery.]: 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.
Preterm Birth [From 20 weeks of gestation to delivery.]: Incidence of preterm birth, defined as delivery before 37 completed weeks of gestation.
Spontaneous Abortion (Miscarriage) [From enrollment (12-14 weeks of gestation) to 20 weeks of gestation.]: Incidence of spontaneous abortion, defined as natural pregnancy loss before 20 weeks of gestation. (Note: Induced abortion is excluded).
Low Birth Weight [At delivery.]: Incidence of low birth weight, defined as neonatal birth weight less than 2500 grams.

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

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.