Maternal Serum Markers Predicting Preeclampsia At Early Gestations

NCT05131282 | Completed

• 1 other identifier: PE_001
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 6

Brief Summary

This observational study aims to assess the effectiveness of a maternal blood test as a prognostic tool for predicting early pregnancy risk of preeclampsia (PE). We hypothesize that specific circulating protein markers may serve as reliable biomarkers for PE risk prediction. Our PE predictor is a standalone blood test designed for early gestation screening to identify pregnancies at risk. This test measures concentrations of four proteins between 11 weeks and 13 weeks+6 days of gestation. Based on the levels of these analytes, the test generates a risk score to classify patients as either low or high risk for PE.

Conditions

Pre-eclampsia; Preterm Birth

Keywords

pre-eclampsia; maternal serum marker; preterm pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• diagnosis of PE during pregnancy

  The primary outcome is the diagnosis of PE during pregnancy, following the America College of Obstetricians and Gynecologists (ACOG, 2019) criteria. This diagnosis will be based on a systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg, measured on multiple occasions after 20 weeks of gestation, alongside proteinuria (dipstick urinalysis ≥ 1+ or a protein/creatinine ratio ≥ 30 mg/mmol \[0.3 mg/mg\]) or other signs of maternal organ dysfunction. PE will be categorized by gestational age at delivery as early-onset (\<34 weeks), preterm (\<37 weeks), or term (≥37 weeks).

  an average of up to 1 year

Secondary Outcomes (1)

• Sensitivity, specificity, PPV and NPV

  an average of up to 1 year

Study Arms (3)

PE group

Women with a confirmative diagnosis of PE

Diagnostic Test: Blood test of PE risk

Normal pregnancy group

Normal pregnant women

Diagnostic Test: Blood test of PE risk; Diagnostic Test: Blood test of Preterm PE risk

Preterm PE group

Women with a confirmative diagnosis of Preterm PE

Diagnostic Test: Blood test of Preterm PE risk

Interventions

Blood test of PE risk DIAGNOSTIC_TEST

A blood test is applied to women between 11weeks and 13 weeks+6 days of GA at the first visit to evaluate risk of developing PE

Normal pregnancy group; PE group

Blood test of Preterm PE risk DIAGNOSTIC_TEST

A blood test is applied to women between 11 weeks and 13 weeks+6 days of GA at the first visit to evaluate risk of developing Preterm PE

Normal pregnancy group; Preterm PE group

Eligibility Criteria

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

Study Population

A multiple-site prospective cohort of women who developed PE (i.e. the PE group) and women who had normal pregnancy (i.e. the Normal group) will be recruited. Maternal serum samples were collected between 11 weeks and 13 weeks+6 days of GA. The two group of women are matched by age, BMI, pregnant history, and other clinical information.

You may qualify if:

• Female participants aged 18 to 40 years.
• Gestational age between 11 weeks and 13 weeks+6 days of GA at the first visit, as confirmed by ultrasound.
• Control group: Pregnancies with no risk factors for preterm delivery, preeclampsia, or fetal growth restriction, selected during routine prenatal care between 11 weeks and 13 weeks+6 days of GA.
• Informed consent to participate in the study.

You may not qualify if:

• Multiple pregnancies.
• Pregestational diabetes.
• Chronic hypertension.
• Systemic diseases (e.g., chronic kidney disease, autoimmune disorders).
• Any maternal or fetal condition necessitating pregnancy termination.
• Known major fetal anomalies or fetal demise.
• Active vaginal bleeding.
• Serious medical illnesses (e.g., renal insufficiency, congestive heart failure, chronic respiratory insufficiency).
• Asthma requiring systemic corticosteroids.
• Use of anti-platelet or non-steroidal anti-inflammatory drugs.
• Active hepatitis.
• Lack of informed consent.

Sponsors & Collaborators

• HBI Solutions Inc.: lead
• Shenzhen Maternity & Child Healthcare Hospital: collaborator
• Eighth Affiliated Hospital, Sun Yat-sen University: collaborator
• Women's Hospital, of Zhejiang University School of Medicine: collaborator
• Third Affiliated Hospital of Zhengzhou University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Hunan Provincial Maternal and Child Health Care Hospital: collaborator

Study Sites (6)

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, Guangdong, China

Location

the Eighth Affiliated Hospital

Shenzhen, Guangdong, China

Location

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Women's Hospital, of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Jianmin Niu, Master

  Shenzhen Maternity and Child Healthcare Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 23, 2021
• Study Start: January 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)