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Diagnostic Value of MicroRNA 210 In Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03193554
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : May 12, 2020
Information provided by (Responsible Party):
Yousra M Farghaly, Assiut University

Brief Summary:

Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic blood pressure 140mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder usually occurs after 20 weeks of pregnancy and worsens over time. Risk factors for pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus, primigravida and pregnant women with multiple gestation .

Healthy women pregnancy can be associated with resistance to the action of insulin on glucose uptake and utilization. Insulin Resistance (IR) is defined as decreased ability of target tissues such as liver, adipose tissue and muscle to respond to normal circulating concentrations of insulin. Insulin Resistance can be a result of a number of factors such as defective molecular structure of insulin, defective receptor functioning or defective signal transduction pathway .

Preeclampsia is associated with increased expression of Tumor necrosis Factor α and other inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to dyslipidemia that can worsen the placental ischemia leading to vicious cycle of ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia . Insulin resistance has also been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who have normotensive pregnancies, women who develop preeclampsia are more insulin resistant prior to pregnancy .

The recognition that specific miRNAs are induced by hypoxia and are commonly dysregulated in preeclampsia raises the possibility that such miRNAs mediate the adverse effects of placental hypoxia in preeclampsia. MiRNAs present in maternal blood may have the potential to be used as biomarkers, as they are relatively stable and tissue specific . It was found that mir-210 is induced in patients with pre-eclampsia, whether mir-210 contributes to the pathogenesis of pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia .

Condition or disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: Diagnostic Value of microRNA 210 In Preeclampsia
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Diagnostic value of MicroRNA 210 in preeclampsia [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women in second trimster divided into 2 groups :

  1. Physiological high risk factor for preeclampsia .
  2. Pregnant women with high insulin resistance.

Inclusion Criteria :Pregnant females that admitted to Women's Health Hospital and they will be divided as follow:

  • Group 1: Pregnant women with insulin resistance .
  • Group 2: Healthy pregnant women as control group .

Exclusion Criteria:

- 1- Female patients with any other type of malignant or benign tumours should be excluded from our study.

2- Past history of chemotherapy or surgical treatment of cancer. 3-Women who diagnosed as preeclamptic or diabetic

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 identifier (NCT number): NCT03193554

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Contact: Lubna Tag El-din, MD 01001085510
Contact: Hanan Mohamed, MD 01223971654

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ASSIUT University Recruiting
Assiut, Egypt
Contact: Lobna         
Assiut Unversity Recruiting
Assiut, Egypt
Contact: Lobna         
Sponsors and Collaborators
Assiut University
Additional Information:

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Responsible Party: Yousra M Farghaly, principal investigator, Assiut University Identifier: NCT03193554    
Other Study ID Numbers: D V O MicroRNA210 I PET
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Hypertension, Pregnancy-Induced
Pregnancy Complications