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Trial record 61 of 147 for:    severe preeclampsia AND hypertensive disorders

Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

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

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.

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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

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903393


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

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

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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    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications