Pre-eclampsia and Biochemical Markers | NCT02665897

Studies
Pre-eclampsia and Biochemical Markers

NCT02665897

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jun 9, 2017Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Detection of Preeclampsia Complications

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 22, 2016

First Submission Date that Met QC Criteria

Jan 25, 2016

First Posted Date

Jan 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2017

Last Update Posted Date

Jun 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group.

This correlates well with the endothelial damage that occurs during pre-eclampsia and thus NGAL can be considered as a promising marker in predicting both early and late onset pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the precision, and sensitivity for detection of risk and reliability of using biomarkers for pre-eclampsia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eclampsia		pregnant women with eclampsia will be diagnosed by the occurrence of seizures on top of preeclampsia.
severe preeclampsia		pregnant women with severe preeclampsia will be diagnosed according to blood pressure ≥160/110 mmHg with proteinuria detection by boiling method +3,+4.
healthy		matched normotensive pregnant women.

Interventions

Not provided

Measure	Description	Time Frame
The level of circulating NGAL		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-40 years.
Gestational age >20 weeks.

Exclusion Criteria:

Patients with preexisting renal disease,hypertension, diabetes mellitus, gestational hypertension.
Patients Refuse to participate in the study
Patients already have complicated preeclampsia.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant women after 20 weeks

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided