NCT07841197Not yet recruiting
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 20 Sept 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- NCT number
- NCT07841197
What you commit to
- Study type: Observational
- Planned participants: 900
- From 20 Sept 2026 to the primary completion date, 31 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Age ≥40 years or <18 years, BMI ≥30 or <18.5, multiple pregnancy, or history of adverse pregnancy outcomes;
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.