NCT03258125

Brief Summary

Preeclampsia is a pregnancy related disease characterized by the new onset of hypertension and proteinuria after 20 weeks of gestation in previously normotensive women. PE is one of the most challenging diseases in obstetrics worldwide that affects 2-8 % of pregnancies causing both morbidity and mortality of both mother and fetus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

August 20, 2017

Last Update Submit

June 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Expression of miRNA-452 and MMP-9.

    real time polymerase chain reaction

    one year

Secondary Outcomes (1)

  • Differences in placental and neonatal weight between the two groups

    one year

Study Arms (2)

severe EOPE

EOPE: PE starting before 34 weeks gestation Severe PE (Blood pressure more than 160/ 110 mm Hg on 2 occasions 2 hours to 2 weeks apart and proteinuria ( 24-hour urine protein \>2000 mg/d).

Genetic: real time PCR (rPCR)

control

Healthy Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weeks gestational age.

Genetic: real time PCR (rPCR)

Interventions

A villus tissue (2.5 cm \* 2.5 cm \* 2.5 cm) will be cut off immediately from the center of placenta, avoiding the area of infarction, bleeding or calcification. After being washed with normal saline, the tissue will be preserved in liquid nitro¬gen at once for subsequent detection of miR-452 and MMP-9 expression by real time PCR (r-PCR). During this procedure total RNA will be extracted including miR-452 and mRNA of MMP-9. Then by reverse transcriptase RNA will be converted into DNA which will be amplification during the PCR, i.e. in real-time, and not at its end, as in conventional PCR. Expression of miR-452 and MMP-9 will be estimated and correlated with each other.

controlsevere EOPE

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women coming for delivery.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weaks gestational age in Assiut university maternity hospital in the age range of 18-40 years.

You may qualify if:

  • Pregnant women who come for termination of pregnancy by vaginal delivery or CS between 28-34 weaks gestational age in Assiut university maternity hospital in the age range of 18-40 years.

You may not qualify if:

  • \) Diabetes mellitus 2) Chronic hypertension 3) Nephropathy 4) Acute or chronic infectious diseases or other chronic illness 5) Twins pregnancy 6) Anti phospholipid antibody syndrome 7) PE complicated with eclampsia, DIC or HELP syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Real-Time Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Ahmed Abbas, MD

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 20, 2017

First Posted

August 23, 2017

Study Start

January 1, 2019

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations