NCT03500588

Brief Summary

In this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with Doppler changes in the pulsatility index of the umbilical artery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

April 10, 2018

Last Update Submit

March 24, 2021

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Correlation of VEGF gene mutation and preeclampsia

    Is VEGF gene polymorphism associated with preeclampsia

    from 20 weeks until delivery

Secondary Outcomes (2)

  • fetal and neonatal outcomes

    from 20 weeks until first postpartum week.

  • maternal outcome

    from 20 weeks until delivery

Study Arms (2)

normotensive pregnant women more than 20 weeks gestation.

One hundred and forty-five pregnant women after 20 weeks with normal blood pressure were evaluated for VEGF gene mutation.

Diagnostic Test: PCR

Pregnant women after 20 weeks with preeclampsia.

One hundred and forty-five pregnant women after 20 weeks with preeclampsia were evaluated for VEGF gene mutation by using PCR and Pulsitality index of umbilical artery by doppler velocimetry.

Diagnostic Test: PCRDevice: Doppler ultrasound

Interventions

PCRDIAGNOSTIC_TEST

Polymerase chain reaction was used to diagnose gene polymorphism.

Pregnant women after 20 weeks with preeclampsia.normotensive pregnant women more than 20 weeks gestation.
Doppler ultrasoundDEVICE

Doppler ultrasound was used to assess the pulsatility index of the umbilical artery .

Pregnant women after 20 weeks with preeclampsia.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

normal and preeclamptic pregnant women after 20 weeks were evaluated for VEGF gene polymorphism.

You may qualify if:

  • More than 20 weeks gestation. Preeclamptic patients

You may not qualify if:

  • association with chronic disease (cardiac, hepatic, renal) and if the patient was known to have chronic hypertension.
  • association with auto-immune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Cairo, Beni Suweif Governorate, 12412, Egypt

Location

Related Publications (4)

  • Lain KY, Roberts JM. Contemporary concepts of the pathogenesis and management of preeclampsia. JAMA. 2002 Jun 26;287(24):3183-6. doi: 10.1001/jama.287.24.3183. No abstract available.

    PMID: 12076198BACKGROUND

  • Huppertz B. Placental origins of preeclampsia: challenging the current hypothesis. Hypertension. 2008 Apr;51(4):970-5. doi: 10.1161/HYPERTENSIONAHA.107.107607. Epub 2008 Feb 7. No abstract available.

    PMID: 18259009BACKGROUND

  • Cooper ME, Vranes D, Youssef S, Stacker SA, Cox AJ, Rizkalla B, Casley DJ, Bach LA, Kelly DJ, Gilbert RE. Increased renal expression of vascular endothelial growth factor (VEGF) and its receptor VEGFR-2 in experimental diabetes. Diabetes. 1999 Nov;48(11):2229-39. doi: 10.2337/diabetes.48.11.2229.

    PMID: 10535459BACKGROUND

  • Chedraui P, Solis EJ, Bocci G, Gopal S, Russo E, Escobar GS, Hidalgo L, Perez-Lopez FR, Genazzani AR, Mannella P, Simoncini T. Feto-placental nitric oxide, asymmetric dimethylarginine and vascular endothelial growth factor (VEGF) levels and VEGF gene polymorphisms in severe preeclampsia. J Matern Fetal Neonatal Med. 2013 Feb;26(3):226-32. doi: 10.3109/14767058.2012.733760. Epub 2012 Oct 18.

    PMID: 23039092BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)