Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

• ClinicalTrials.gov Identifier: NCT03903393
• Recruitment Status: Recruiting
• First Posted: April 4, 2019
• Last Update Posted: April 5, 2019
• Sponsor: First Affiliated Hospital of Harbin Medical University
• Information provided by (Responsible Party): First Affiliated Hospital of Harbin Medical University

Study Description

Brief 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 .

Condition or disease
Preeclampsia

Detailed 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 260 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia
• Actual Study Start Date: March 31, 2019
• Estimated Primary Completion Date: March 31, 2019
• Estimated Study Completion Date: March 31, 2021

Groups and Cohorts

Group/Cohort
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.
controls; Normal pregnant women

Outcome Measures

Primary Outcome Measures :

1. The RNA expression levels of lncRNAs [ Time Frame: 5 months ]
   the serum of patients with preeclampsia and in the serum of normal controls were measured by qRT-PCR.

Biospecimen Retention:   Samples With DNA

1. the serum of the pregnant women
2. the placenta of the pregnant women after delivery

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Preeclamptic women Controls

Criteria

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.

Contacts and Locations

Contacts

Contact: Yue Li, MD; 86-451-85555673; ly99ly@vip.163.com

Locations

China, Heilongjiang

Serum LncRNAs as Potential Biomarkers for the Prediction of Preeclampsia; Recruiting

Harbin, Heilongjiang, China, 150001

Contact: Dai Chenguang, MD 13766875068 dcg866@163.com

Sponsors and Collaborators

First Affiliated Hospital of Harbin Medical University

Investigators

• Principal Investigator: Yue Li; First Affiliated Hospital of Harbin Medical University

More Information

• Responsible Party: First Affiliated Hospital of Harbin Medical University
• ClinicalTrials.gov Identifier: NCT03903393 History of Changes
• Other Study ID Numbers: 201933
• First Posted: April 4, 2019
• Last Update Posted: April 5, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications