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Status unknownNCT03903393Updated Dec 17, 2019

Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

An observational study in Preeclampsia, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 1 site in China. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by First Affiliated Hospital of Harbin Medical University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
260
Ages
20 Years to 45 Years
Sex
Female
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Study 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 .

Read the 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.

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Conditions studied

  • Preeclampsia

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03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 260 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Preeclamptic women Controls

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
260 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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What researchers measure

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.

    Time frame: 5 months

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Study locations

1 of 1 sites recruiting
  • Serum LncRNAs as Potential Biomarkers for the Prediction of Preeclampsia
    Harbin, Heilongjiang 150001, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03903393
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Responsible party
Sponsor
First posted
Apr 4, 2019
Start date
Mar 31, 2019
Primary completion
Mar 2021 (estimated)
Completion
Mar 2021 (estimated)
Last update
Dec 17, 2019

Study contacts

Yue Li, MD
Contact
ly99ly@vip.163.com
86-451-85555673
Yue Li
principal investigator · First Affiliated Hospital of Harbin Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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