Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

NCT03903393 | Unknown

• 1 other identifier: 201933
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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 .

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Preeclamptic women Controls

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

Serum LncRNAs as Potential Biomarkers for the Prediction of Preeclampsia

Harbin, Heilongjiang, 150001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Yue Li

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Li, MD

CONTACT

86-451-85555673; ly99ly@vip.163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: March 31, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 17, 2019

Record last verified: 2019-03

Locations

CN (1)