NCT06329284

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 10, 2024

Last Update Submit

March 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severity of Pre-Eclampsia (PE)

    Correlation between Serum midkine levels and blood pressure measurements

    8 months

Study Arms (1)

Serum Midkine

OTHER
Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

ELISA estimation of serum Midkine, tumor necrosis factor Alfa, superoxide dismutase, malondialdehyde, placental growth factor and placental soluble fms-like tyrosine kinase 1

Serum Midkine

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Newly pregnant normotensive (NT) women with singleton fetus;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University

Banhā, El- Qalyobia, 13511, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Newly pregnant normotensive (NT) women with singleton fetus
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics & Gynecology, Faculty of Medicine

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 25, 2024

Study Start

January 1, 2023

Primary Completion

September 15, 2023

Study Completion

December 15, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations