NCT07119034

Brief Summary

Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

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

November 1, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

9 days

First QC Date

August 5, 2025

Last Update Submit

August 11, 2025

Conditions

Preeclampsia (PE)Oxidative Stress

Outcome Measures

Primary Outcomes (2)

  • Oxadative stress parameters

    Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde

    7 months

  • Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde

    Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde

    7 months

Other Outcomes (1)

  • Preeclampsia parameters

    7 months

Study Arms (2)

Control group

control group comprising 45 healthy pregnant women

Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)

Preeclampsia group

Preeclampsia group 45 women with preeclampsia

Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)

Interventions

Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)DIAGNOSTIC_TEST

Blood samples were collected from the antecubital vein and processed at the TrueLab medical laboratory. The whole blood was initially collected in plain tubes, and subsequently centrifuged to obtain serum samples. Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) Thioredoxin and 4-Hydroxynonenal quantification, malondialdehyde levels

Control groupPreeclampsia group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study population, comprising preeclamptic and healthy pregnant women, was meticulously defined using anthropometric questionnaires and consideration of relevant medical features
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

45 with preeclampsia who completed the questionnaire, providing all necessary data

You may not qualify if:

  • applied to those with diabetes, liver or kidney diseases, cardiovascular diseases, or using specific supplements like vitamins A, C, and E.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Ahliyya Amman University

Amman, 19328, Jordan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were collected from the antecubital vein and processed at the TrueLab medical laboratory. The whole blood was initially collected in plain tubes, and subsequently centrifuged to obtain serum samples. Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels were measured. The remaining serum samples were stored at -80°C until analysis at AAU's clinical laboratory, utilizing Enzyme-linked immunosorbent assay (ELISA) for Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde levels were measured using a colorimetric assay.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Doaa El-Bohy, PhD

    Al-Ahliyya Amman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of clinical Pharmacy

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

November 1, 2022

Primary Completion

November 10, 2022

Study Completion

May 1, 2023

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

JO(1)