Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-31

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To identify lncRNAs differentially expressed at early stages of gestation in the serum of pregnant women, who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with normal pregnancy .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Preeclampsia (PE) is a pregnancy syndrome characterized by hypertension and proteinuria, and a leading cause of maternal and fetal morbidity and mortality, with poorly defined pathophysiological mechanisms remain. Circulating lncRNAs are long, noncoding RNA molecules, which negatively regulate gene expression, and considered as promising biomarkers for PE. The objective of the study is to evaluate circulating lncRNA signatures in women with PE compared to healthy women, and in women sub-grouped per PE severity. This study assessed lncRNA expression profile in the serum at early stages of gestation of women who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with uncomplicated pregnancies. Circulating lncRNA was extracted from maternal serum. This study also assess lncRNA expression profile in the placenta tissues of PE patients and healthy pregnant women.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preeclampsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

preeclamptic women

systolic blood pressure(BP) ≥140 mm Hg or diastolic BP ≥90 mm Hg; hypertension diagnosed after 20 weeks gestation; new-onset hypertension with new-onset proteinuria or other signs/symptoms of preeclampsia after 20 weeks or chronic proteinuria with newonset hypertension.

No interventions assigned to this group

controls

Normal pregnant women

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* new onset hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg on two occasions at least 4 h apart) after 20 weeks of gestation in women who previously had normal blood pressure.
* proteinuria (the excretion of 300 mg or more of protein in a 24-hour urine collection)or other signs/symptoms of preeclampsia after 20 weeks of gestation in women who previously had normal blood pressure.

Exclusion Criteria

* maternal infections
* smoking
* chemical dependency
* known major foetal or chromosomal anomalies
* intrahepatic cholestasis during pregnancy
* assisted reproductive technology (ART) treatments
* chronic hypertension.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yue Li

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Serum LncRNAs as Potential Biomarkers for the Prediction of Preeclampsia

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yue Li, MD

Role: CONTACT

Phone: 86-451-85555673

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dai Chenguang, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201933

Identifier Type: -

Identifier Source: org_study_id