An observational study in Preeclampsia, Premature Birth and Fetal Growth Restriction, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 900 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
pregnant women
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal nucleosome and PLGF group
Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels
Nucleosome-elevated only group
Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels
PLGF-elevated only group
Other: Measurement of plasma nucleosome and placental growth factor (PLGF) levels
Nucleosome and PLGF elevated group
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.
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.
Time frame: From enrollment (12-14 weeks of gestation) to delivery (up to 40 weeks of gestation).
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.
Time frame: 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.
Time frame: From 20 weeks of gestation to delivery.
Preterm Birth
Incidence of preterm birth, defined as delivery before 37 completed weeks of gestation.
Time frame: 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).
Time frame: 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.
Time frame: At delivery.
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University →