PreeclampsiaNCT07841197
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
An observational study of Preeclampsia and Premature Birth, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Premature Birth, Fetal Growth Restriction
- What is being tested?
- Measurement of plasma nucleosome and placental growth factor (PLGF) levels
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Being tested
- Measurement of plasma nucleosome and placental growth factor (PLGF) levels
- Keywords
- Placental Growth Factor, Nucleosomes, Adverse Pregnancy Outcomes
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Fetal Growth Retardation, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of plasma nucleosome and placental growth factor (PLGF) levelsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal nucleosome and PLGF group | Normal nucleosome and PLGF group Receives: Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels | |
| Nucleosome-elevated only group | Nucleosome-elevated only group Receives: Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels | |
| PLGF-elevated only group | PLGF-elevated only group Receives: Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels | |
| Nucleosome and PLGF elevated group | Nucleosome and PLGF elevated group Receives: Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (12-14 weeks of gestation) to delivery (up to 40 weeks of gestation).
Secondary outcomes (5)
Preeclampsia
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.
Measured: From 20 weeks of gestation to delivery (up to 40 weeks of gestation).
Fetal Growth Restriction (FGR)
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.
Measured: From 20 weeks of gestation to delivery.
Preterm Birth
Incidence of preterm birth, defined as delivery before 37 completed weeks of gestation.
Measured: From 20 weeks of gestation to delivery.
Spontaneous Abortion (Miscarriage)
Incidence of spontaneous abortion, defined as natural pregnancy loss before 20 weeks of gestation. (Note: Induced abortion is excluded).
Measured: From enrollment (12-14 weeks of gestation) to 20 weeks of gestation.
Low Birth Weight
Incidence of low birth weight, defined as neonatal birth weight less than 2500 grams.
Measured: At delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Hua, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841197
- Sponsor's protocol ID
- SAHoWMU-CR2026-07-209
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No