Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

Preeclampsia Clinical Trial

Official title:

Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03903393
• Other study ID #: 201933
• Status: Recruiting
• Start date: March 31, 2019
• Est. completion date: March 2021

Study information

• Verified date: March 2019
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yue Li, MD
• Phone: 86-451-85555673
• Email: ly99ly[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
China	Serum LncRNAs as Potential Biomarkers for the Prediction of Preeclampsia	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The RNA expression levels of lncRNAs	the serum of patients with preeclampsia and in the serum of normal controls were measured by qRT-PCR.	5 months