NCT05294952

Brief Summary

Preeclampsia is a form of hypertensive pregnancy disorder with multiorgan involvement. It is characterized by new-onset hypertension and proteinuria after 20 weeks' gestation in a woman whose blood pressure was normal before pregnancy. The condition may be serious and is a leading cause of preterm birth (before 37 weeks of pregnancy). If it is severe enough it may affect the brain function, causing seizures or coma, this is called eclampsia

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_4

Status
not yet recruiting

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

March 4, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

March 4, 2022

Last Update Submit

February 1, 2024

Conditions

Keywords

coinhibtory receptor

Outcome Measures

Primary Outcomes (1)

  • early detection of preeclampsia

    detection levels of co inhibtory receptor

    1year

Study Arms (2)

preeclampsiapregnant women

EXPERIMENTAL

Inclusion criteria A total of 41 women in third trimester pregnancy complicated with PE showing: * Blood pressure ≥140/90 mmHg and * Proteinuria ≥300 mg/24 hours with or without * Edema in pregnant woman after week 20 of gestation (American Congress of Obstetricians and Gynecologists (ACOG2013) (17) B-Exclusion criteria * Patients with autoimmune, acute inflammatory, and chronic diseases, are excluded from the study.

Genetic: real time PCR

normal pregnant women

NO INTERVENTION

This will include age matched 41 normal pregnant women in their third trimester of pregnancy with normal blood pressure, absence of proteinuria, and without any other systemic or endocrine disorder.

Interventions

diagnostic test

Also known as: ELISA
preeclampsiapregnant women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • total of 41 women in third trimester pregnancy complicated with PE showing:
  • Blood pressure ≥140/90 mmHg and
  • Proteinuria ≥300 mg/24 hours with or without
  • Edema in pregnant woman after week 20 of gestation (American Congress of Obstetricians and Gynecologists (ACOG2013) (17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Real-Time Polymerase Chain ReactionEnzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesImmunoenzyme TechniquesImmunoassayImmunologic TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: preeclasmpsia pregnant women and normal pregnant women
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
real time PCR

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 24, 2022

Study Start

January 1, 2025

Primary Completion

February 3, 2025

Study Completion

November 4, 2025

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share