NCT05131282Completed
Maternal Serum Markers Predicting Preeclampsia At Early Gestations
An Observational Study of a Maternal Blood Protein Predictor for Case Finding of Pregnancies At Risk of Preeclampsia At Early Gestation
Source: ClinicalTrials.gov · Last updated 25 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 18000 (actual)
- First submitted
- 29 Oct 2021
- Start date
- 1 Jan 2019
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- HBI Solutions Inc.
- NCT number
- NCT05131282
What you commit to
- Study type: Observational
- Participants enrolled: 18000
- From 1 Jan 2019 to the primary completion date, 30 Jun 2023
- 6 sites in 1 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Asthma requiring systemic corticosteroids.
Other illness
- Pregestational diabetes.
- Chronic hypertension.
- Systemic diseases (e.g., chronic kidney disease, autoimmune disorders).
- Any maternal or fetal condition necessitating pregnancy termination.
- Active vaginal bleeding.
- Serious medical illnesses (e.g., renal insufficiency, congestive heart failure, chronic respiratory insufficiency).
- Active hepatitis.
Lab values
- Use of anti-platelet or non-steroidal anti-inflammatory drugs.
Other
- Multiple pregnancies.
- Known major fetal anomalies or fetal demise.
- Lack of informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Provincial Maternal and Child Health Care Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Women's Hospital, of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| the Eighth Affiliated Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shenzhen Maternity & Child Healthcare Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Third Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.