NCT03193554

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

June 18, 2017

Last Update Submit

May 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value of MicroRNA 210 in preeclampsia

    1 Year

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • \- 1- Female patients with any other type of malignant or benign tumours should be excluded from our study.
  • Past history of chemotherapy or surgical treatment of cancer. 3-Women who diagnosed as preeclamptic or diabetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ASSIUT University

Asyut, Egypt

RECRUITING

Assiut Unversity

Asyut, Egypt

RECRUITING

Related Publications (7)

  • Al-Jameil N, Aziz Khan F, Fareed Khan M, Tabassum H. A brief overview of preeclampsia. J Clin Med Res. 2014 Feb;6(1):1-7. doi: 10.4021/jocmr1682w. Epub 2013 Dec 13.

    PMID: 24400024BACKGROUND
  • Bueno MJ, Perez de Castro I, Malumbres M. Control of cell proliferation pathways by microRNAs. Cell Cycle. 2008 Oct;7(20):3143-8. doi: 10.4161/cc.7.20.6833. Epub 2008 Oct 20.

    PMID: 18843198BACKGROUND
  • Eiland E, Nzerue C, Faulkner M. Preeclampsia 2012. J Pregnancy. 2012;2012:586578. doi: 10.1155/2012/586578. Epub 2012 Jul 11.

    PMID: 22848831BACKGROUND
  • Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

    PMID: 24150027BACKGROUND
  • Morales Prieto DM, Markert UR. MicroRNAs in pregnancy. J Reprod Immunol. 2011 Mar;88(2):106-11. doi: 10.1016/j.jri.2011.01.004. Epub 2011 Feb 25.

    PMID: 21353310BACKGROUND
  • Roberts JM, Lain KY. Recent Insights into the pathogenesis of pre-eclampsia. Placenta. 2002 May;23(5):359-72. doi: 10.1053/plac.2002.0819.

    PMID: 12061851BACKGROUND
  • Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.

    PMID: 20598363BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Lubna Tag El-din, MD

CONTACT

Hanan Mohamed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 18, 2017

First Posted

June 21, 2017

Study Start

January 1, 2019

Primary Completion

May 1, 2020

Study Completion

August 30, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations