Midkine Role With Deregulated Oxidative and Immune Milieu... | NCT06329284

Studies
Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia

NCT06329284

Sponsor

Benha University

Status

Completed

Last Update Posted

Mar 26, 2024Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Pre-Eclampsia

Interventions

ELISA

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

Mar 2024

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 1, 2023Actual

Primary Completion Date

Sep 15, 2023Actual

Completion Date

Dec 15, 2023Actual

First Submitted Date

Mar 10, 2024

First Submission Date that Met QC Criteria

Mar 22, 2024

First Posted Date

Mar 25, 2024Actual

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

Mar 24, 2024

Last Update Posted Date

Mar 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shereen Naguib, Lecturer of Obstetrics & Gynecology, Faculty of Medicine, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.

Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Serum Midkine	Other		Diagnostic Test: ELISA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ELISA	Diagnostic Test	ELISA estimation of serum Midkine, tumor necrosis factor Alfa, superoxide dismutase, malondialdehyde, placental growth factor and placental soluble fms-like tyrosine kinase 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of Pre-Eclampsia (PE)	Correlation between Serum midkine levels and blood pressure measurements	8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly pregnant normotensive (NT) women with singleton fetus;
Free of the Exclusion Criteria.

Exclusion Criteria:

Women with history of complicated pregnancy;
Had manifest essential hypertension, Diabetes Mellitus or chronic kidney diseases;
Had multiple gestational sacs, morbid obesity with Body Mass Index at time of pregnancy diagnosis over 35 kg/m2;
Had genetic disorders, coagulopathy, autoimmune diseases or maintained on immunosuppressive therapy.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banha University		Banhā	El- Qalyobia	13511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided