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NCT07841197

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

Sponsor: Second Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

900

Start Date

2026-09-20

Completion Date

2027-12-31

Last Updated

2026-09-25

Healthy Volunteers

Yes

Interventions

OTHER

Measurement of plasma nucleosome and placental growth factor (PLGF) levels

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.