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

NCT07841197 | Not Yet Recruiting

• 1 other identifier: SAHoWMU-CR2026-07-209
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Preeclampsia; Premature Birth; Fetal Growth Restriction; Recurrent Miscarriage

Keywords

Placental Growth Factor; Nucleosomes; Adverse Pregnancy Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• 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.

Study Arms (4)

Normal nucleosome and PLGF group

Normal nucleosome and PLGF group

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

Nucleosome-elevated only group

Nucleosome-elevated only group

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

PLGF-elevated only group

PLGF-elevated only group

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

Nucleosome and PLGF elevated group

Nucleosome and PLGF elevated group

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

Interventions

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.

Normal nucleosome and PLGF group; Nucleosome and PLGF elevated group; Nucleosome-elevated only group; PLGF-elevated only group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth; Fetal Growth Retardation; Abortion, Habitual

Interventions

Prostaglandins F; Floors and Floorcoverings

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abortion, Spontaneous

Intervention Hierarchy (Ancestors)

Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 25, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09